February 28, 2022 at 11:25PM Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement - 03/03/2022

This is the CBER Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement.

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February 28, 2022 at 09:19PM NovoSevenRT

Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.

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February 28, 2022 at 09:15PM New Drug Applications (NDAs)

List of new drug applications

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February 28, 2022 at 09:09PM Nabi-HB

Product approval information is indicated for:
•Treatment of acute exposure to HBsAg following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure of infants to persons with acute hepatitis B virus infection.
•For the treatment of acute exposure to HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure of infants to persons with acute HBV infection.

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February 28, 2022 at 09:08PM Multispot HIV-1/HIV-2 Rapid Test

For the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2

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February 28, 2022 at 08:35PM MedMira Reveal Rapid HIV-1 Antibody Test

Detection of antibodies to HIV-1 in human serum or plasma specimens

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February 28, 2022 at 08:29PM MedMira Reveal G2 Rapid HIV-1 Antibody Test

To allow for the addition of a procedural and reagent control line, a change in the packaging of the Colorimetric Detection Agent, and a change in the name of the device to Reveal TM G2 Rapid HIV-1 Antibody Test

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February 28, 2022 at 07:22PM FDA Voices on Policy

FDA Voices on Policy

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February 28, 2022 at 07:07PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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February 25, 2022 at 10:39PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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February 25, 2022 at 10:14PM Study of the regulation of blood coagulation by factors VIIa and IXa

A description of Mikhail Ovanesov's research program and related publications.

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February 25, 2022 at 09:50PM KEDRAB

• Product approval information is indicated for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and concurrently with a full course of rabies vaccine.

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February 25, 2022 at 09:03PM Evaluation and Characterization of Neutralizing Antibodies against Viruses Relevant to Blood-derived Products

A description of Pei Zhang's research program and related publications.

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February 25, 2022 at 08:58PM InterSol Solution/Platelet Additive Solution 3

InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of AMICUS derived leukoreduced apheresis platelets. Posted: 12/10/2009

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February 25, 2022 at 08:45PM eCTD TECHNICAL CONFORMANCE GUIDE

This Document is incorporated by reference into the following
Guidance Document(s):
Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications

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February 24, 2022 at 01:42PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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February 25, 2022 at 06:06PM Information regarding the OraQuick In-Home HIV Test

The OraQuick In-Home HIV Test is a rapid self-administered over-the-counter (OTC) test. Answers are provided to common questions about the product.

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February 25, 2022 at 05:52PM Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

Procedural Guidance

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February 25, 2022 at 05:28PM Immune Globulins

Lists of immune globulins fractionated plasma products blood.

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February 25, 2022 at 04:49PM Clinical Guidances

This page lists Clinical Guidance documents.

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February 25, 2022 at 03:00PM Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

Procedural Guidance

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February 23, 2022 at 11:10PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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February 23, 2022 at 10:13PM Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens

A description of Drusilla Burns' research program and related publications.

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February 23, 2022 at 10:12PM IDELVION

Product approval information is indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for 1) On-demand control and prevention of bleeding episodes; 2) Perioperative management of bleeding; 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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February 23, 2022 at 09:49PM HYQVIA

Indicated for the treatment of Primary Immunodeficiency (PI) in adults.

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February 23, 2022 at 09:38PM Home Access HIV-1 Test System

For self-use by people who wish to obtain anonymous HIV testing.

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February 23, 2022 at 09:28PM Hizentra

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

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February 23, 2022 at 09:02PM HepaGam B

Product approval information is indicated for
•The prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Also indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.
•Treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.

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February 23, 2022 at 08:56PM Learn More About COVID-19 Vaccines from the FDA

Get answers to your questions about the standards for safety and effectiveness to support an emergency use authorization of COVID-19 vaccines.

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February 23, 2022 at 08:54PM HAEGARDA

Product approval information is indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

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February 22, 2022 at 08:06PM Fractionated Plasma Products

Listing of fractionated plasma products

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February 22, 2022 at 11:23PM Safety and Effectiveness of Gene Therapy

A description of Andrew Byrnes' research program and related publications.

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February 22, 2022 at 08:52PM Gammagard S/D

Product approval information is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

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February 22, 2022 at 08:50PM Gammagard Liquid

Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

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February 22, 2022 at 08:30PM GamaSTAN S/D, Immune Globulin (Human)

use in immunocompromised patients for passive immunization 48 against varicella if Varicella-Zoster Immune Globulin (Human) is not available.

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February 22, 2022 at 04:02PM Drug Product Tracing: The Effect of Section 585 of the FD&C Act

Procedural

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February 22, 2022 at 03:45PM Smart Surgical, Inc dba Burst Biologics - 614361 - 02/02/2022

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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February 22, 2022 at 03:31PM Toxikon Corporation/Labcorp Bedford LLC - 623581 - 02/10/2022

Good Laboratory Practice (GLP)

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Justin Bieber tests positive for Covid, reschedules Las Vegas show - CNN

1. Justin Bieber tests positive for Covid, reschedules Las Vegas show  CNN
2. Justin Bieber postpones concert due to COVID-19 outbreak within his "Justice World Tour" team | ABC7  ABC7
3. Justin Bieber Tests Positive for COVID-19, Tour Date Postponed  TMZ
4. Justin Bieber's show at T-Mobile Arena in Las Vegas Sunday postponed  KTNV Las Vegas
5. Justin Bieber Tests Positive for COVID-19, Postpones Las Vegas Concert Date  PEOPLE

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Australia welcomes back tourists with toy koalas, Tim Tams - Associated Press

1. Australia welcomes back tourists with toy koalas, Tim Tams  Associated Press
2. 'Welcome back world!': Australia fully reopens borders after two years  Reuters
3. As Australia reopens, crippled tourism sector feels cautious hope  Al Jazeera English
4. Australia reopening borders to tourists on Monday | TheHill  The Hill
5. Australia Finally Lifts Its 2-Year Travel Restrictions Since Covid Outbreak  Bloomberg
6. View Full Coverage on Google News

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Justin Bieber tests positive for COVID-19, cancels Las Vegas show - Page Six

1. Justin Bieber tests positive for COVID-19, cancels Las Vegas show  Page Six
2. Justin Bieber Tests Positive for COVID-19, Tour Date Postponed  TMZ
3. Justin Bieber Tests Positive for COVID-19, Postpones Las Vegas Concert Date  PEOPLE
4. Justin Bieber's show at T-Mobile Arena in Las Vegas Sunday postponed  KTNV Las Vegas
5. Justin Bieber Postpones Las Vegas Concert Date Due to COVID-19 Outbreak on His Team  Yahoo! Voices
6. View Full Coverage on Google News

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Justin Bieber Tests Positive for COVID-19, Tour Date Postponed - TMZ

1. Justin Bieber Tests Positive for COVID-19, Tour Date Postponed  TMZ
2. Justin Bieber Postpones Las Vegas Concert Date Due to COVID-19 Outbreak on His Team  Yahoo Entertainment
3. Justin Bieber tests positive for COVID-19 and postpones Las Vegas concert to the summer  Daily Mail
4. Justin Bieber's show at T-Mobile Arena in Las Vegas Sunday postponed  KTNV Las Vegas
5. Justin Bieber reportedly tests positive for COVID after San Diego show  fox5sandiego.com
6. View Full Coverage on Google News

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Justin Bieber Tests Positive for COVID-19, Tour Date Postponed - TMZ

1. Justin Bieber Tests Positive for COVID-19, Tour Date Postponed  TMZ
2. Justin Bieber Postpones Las Vegas Concert Date Due to COVID-19 Outbreak on His Team  PEOPLE
3. Justin Bieber cancels Las Vegas date; moves show to June  Las Vegas Review-Journal
4. Justin Bieber's show at T-Mobile Arena in Las Vegas Sunday postponed  KTNV Las Vegas
5. Justin Bieber's Las Vegas show postponed due to COVID  News3LV
6. View Full Coverage on Google News

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February 18, 2022 at 10:59PM De Novo Classification Process (Evaluation of Automatic Class III Designation)

The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request. 

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February 18, 2022 at 09:20PM FDA Roundup: February 18, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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February 18, 2022 at 07:35PM Acceptance Review for De Novo Classification Requests

This guidance discusses De Novo acceptance policies and procedures, Refuse to Accept principles, and the Acceptance Checklist for De Novo Requests.

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February 18, 2022 at 07:55PM SPIKEVAX

COVID19 Vaccine, mRNA

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February 18, 2022 at 06:37PM Afluria, Afluria Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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February 17, 2022 at 11:10PM Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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FDA says parents should avoid certain powdered baby formula after reports of 4 bacterial infections - CNN

1. FDA says parents should avoid certain powdered baby formula after reports of 4 bacterial infections  CNN
2. FDA Warns Parents Not To Use Some Similac, Alimentum And EleCare Powdered Infant Formula  CBS Boston
3. Listeria outbreak grows; new outbreak linked to infant formula kills one  Food Safety News
4. FDA: Do not use recalled infant formulas tied to infections  CBS46 Atlanta
5. Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant  PRNewswire
6. View Full Coverage on Google News

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February 17, 2022 at 03:27PM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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February 16, 2022 at 10:30PM Flebogamma DIF 5% & 10%

Product approval information is indicated for:
•Flebogamma 5% DIF: Treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
•Flebogamma 10% DIF: Treatment of (1) primary (inherited) immunodeficiency; (2) chronic primary immune thrombocytopenia (ITP) in patients 2 years of age and older.

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February 16, 2022 at 10:26PM Flebogamma DIF 10%

Flebogamma 10% DIF is a human immune globulin intravenous (IGIV) indicated for the 11 treatment of primary humoral immunodeficiency (PI).

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February 16, 2022 at 10:02PM FIBRYGA

For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

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Hong Kong overwhelmed by thousands of coronavirus cases, as “zero covid” policy fails - The Washington Post

1. Hong Kong overwhelmed by thousands of coronavirus cases, as “zero covid” policy fails  The Washington Post
2. Omicron Reveals Hong Kong's Covid Dilemma  The New York Times
3. Hong Kong's outbreak shows the limits of zero-Covid -- but the government isn't budging  CNN
4. Xi urges Hong Kong to get control as COVID-19 cases surge  Associated Press
5. Hong Kong under pressure as record COVID outbreak stretches hospitals to limit  ABC News
6. View Full Coverage on Google News

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February 16, 2022 at 01:38PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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Omicron Reveals Hong Kong's Covid Dilemma - The New York Times

1. Omicron Reveals Hong Kong's Covid Dilemma  The New York Times
2. Hong Kong's outbreak shows the limits of zero-Covid -- but the government isn't budging  CNN
3. Hong Kong overwhelmed by thousands of coronavirus cases, as “zero covid” policy fails  The Washington Post
4. Xi urges Hong Kong to get control as COVID-19 cases surge  Associated Press
5. Xi tells Hong Kong to control Omicron-fuelled outbreak  Al Jazeera English

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Hong Kong's outbreak shows the limits of zero-Covid -- but the government isn't budging - CNN

1. Hong Kong's outbreak shows the limits of zero-Covid -- but the government isn't budging  CNN
2. Xi urges Hong Kong to get control as COVID-19 cases surge  Associated Press
3. Xi tells Hong Kong to control Omicron-fuelled outbreak  Al Jazeera English
4. China's Xi sets Hong Kong's leaders 'overriding mission' to control COVID - media  Reuters
5. Summary of the Lastest Hong Kong's Covid Outbreak: What Happened in This Month?  Bloomberg
6. View Full Coverage on Google News

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Xi tells Hong Kong to control Omicron-fuelled outbreak - Al Jazeera English

1. Xi tells Hong Kong to control Omicron-fuelled outbreak  Al Jazeera English
2. Hong Kong's outbreak shows the limits of zero-Covid -- but the government isn't budging  CNN
3. China's Xi sets Hong Kong's leaders 'overriding mission' to control COVID - media  Reuters
4. Xi urges Hong Kong to get control as COVID-19 cases surge  Associated Press
5. China's Xi: Control of Hong Kong surge is 'overriding task'  WHIO Radio
6. View Full Coverage on Google News

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February 15, 2022 at 03:41PM COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L

Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers

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February 15, 2022 at 03:39PM Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

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February 15, 2022 at 03:13PM Coagulation Factors

Lists of the Coagulation Factors products

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February 15, 2022 at 03:04PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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February 14, 2022 at 11:04PM Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about the emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19.

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February 14, 2022 at 11:11PM Blood Research

List of Blood Research Programs in Biologics

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February 14, 2022 at 11:11PM Ex Vivo Stored Blood Component Safety and Quality: Evaluation of Novel Methods for Pathogen Reduction and Functional Regulation in Blood Components

A description of C. D. Atreya's research program and related publications.

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February 14, 2022 at 04:11PM ATryn

Product approval information is indicated for the prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients.

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February 14, 2022 at 04:07PM Atgam

Product approval information is indicated for:
o The management of allograft rejection in renal transplant patients.
o The treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation.

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February 14, 2022 at 04:03PM ARTISS

Product approval information is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.

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February 14, 2022 at 03:22PM Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated Products

List including applications in alphabetical order by product name for which have approval documents available, and reflects the information as of the approval date.

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February 14, 2022 at 03:12PM Antithrombin (Recombinant)

A list of Antithrombin (Recombinant)products.

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February 14, 2022 at 03:11PM Anti-Inhibitor Coagulant Complex

Lists of Anti-Inhibitor Coagulant Complex product.

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February 14, 2022 at 02:51PM International Engagements to Respond to Covid-19 Pandemic

International Engagements to Respond to Covid-19 Pandemic

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February 11, 2022 at 10:15PM Biologics Export Certification Application and Tracking System (BECATS) Frequently Asked Questions

This is the Frequently Asked Questions for the Biologics Export Certification Application and Tracking System (BECATS).

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February 11, 2022 at 09:44PM Antihemophilic Factor (Recombinant)

Lists contain the Antihemophilic Factor (Recombinant) products with supporting documents.

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February 11, 2022 at 06:01PM Anticoagulant Citrate Phosphate Dextrose Solution (CPD)

Product approval information is indicated for a single Whole Blood collection of 500 mL ± 10%.

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February 11, 2022 at 05:45PM ANTHRASIL

Product approval information is the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.

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February 11, 2022 at 05:29PM ANAVIP

Product approval information is indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.

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February 11, 2022 at 05:05PM Anascorp

Anascorp is indicated for the treatment of clinical signs of scorpion envenomation.

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February 11, 2022 at 04:35PM ALPROLIX

Product approval information is indicated for adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes, (2) Perioperative management, (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

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February 11, 2022 at 04:23PM Alphanate

Product approval information is indicated for:
•Control and prevention of bleeding in patients with hemophilia A or acquired Factor VIII (FVIII) deficiency (1.1)
•Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery (1.2)

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February 10, 2022 at 06:32PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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February 10, 2022 at 05:23PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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February 10, 2022 at 03:44PM How do I prepare for a Patient Listening Session?

Learn about how you can prepare to participate in a Patient Listening Session. Patient Listening Sessions can be FDA-requested or patient-led.

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February 09, 2022 at 10:00PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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February 09, 2022 at 09:52PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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February 09, 2022 at 09:41PM How do I request a Patient Listening Session?

Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.

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Elon Musk’s SpaceX Seeks to Reconnect Tonga to Internet - The Wall Street Journal

1. Elon Musk’s SpaceX Seeks to Reconnect Tonga to Internet  The Wall Street Journal
2. Musk helping restore Tongan internet; virus outbreak growing  KSL.com
3. Elon Musk helping restore internet to Tonga, officials say  WHIO Radio
4. SpaceX working to reconnect Tonga’s internet after volcanic eruption  The Independent
5. SpaceX Starlink is restoring internet in Tonga after Elon Musk's offer  Business Insider
6. View Full Coverage on Google News

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February 09, 2022 at 08:56PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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February 08, 2022 at 04:46PM AFSTYLA

AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes,
• Routine prophylaxis to reduce the frequency of bleeding episodes,
• Perioperative management of bleeding.

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February 09, 2022 at 05:05PM Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.

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February 08, 2022 at 10:29PM Innovation to Respond to COVID-19

Learn about FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible.

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February 08, 2022 at 04:35PM ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents

For qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma

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February 08, 2022 at 04:32PM Advate

Product approval information indicated for:
◦Control and prevention of bleeding episodes in adults and children (0-16 16 years) with Hemophilia A.
◦Perioperative management in adults and children (0-16 years) with 18 Hemophilia A.
◦Routine prophylaxis to prevent or reduce the frequency of bleeding 20 episodes in adults and children (0-16 years) with Hemophilia A.
•Advate is not indicated for the treatment of von Willebrand disease.

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February 08, 2022 at 04:28PM Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit

Product approval information is indicated for quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers.

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February 08, 2022 at 02:09PM OTAT Learn

Welcome to OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education.

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February 07, 2022 at 10:12PM 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven 500 mL freeflex flexible plastic intravenous solution container)

Product approval information is indicated for treatment and prophylaxis of hypovolemia in adults and children.

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February 07, 2022 at 09:43PM T.R.U.E. TEST

Product approval information for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 allergens and allergen mixes included on the T.R.U.E. TEST panels.

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February 07, 2022 at 09:24PM Spherusol

Spherusol is a product approval information for the detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis.

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February 07, 2022 at 09:13PM RAGWITEK

Product approval information for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen approved for use in adults 18 through 65 years of age.

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February 07, 2022 at 09:07PM ORALAIR

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.

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February 07, 2022 at 08:46PM ODACTRA

Product approval information for use in adults 18 through 65 years of age as immunotherapy for house dust mite- (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts.

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February 07, 2022 at 08:20PM GRASTEK

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age

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February 07, 2022 at 05:46PM Drug Product Tracing: The Effect of Section 585 of the FD&C Act instead of FDA’s guidance on uniform national policy

Procedural

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February 07, 2022 at 02:52PM Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

Clinical Pharmacology

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February 04, 2022 at 08:26PM CANDIN

Submission Tracking Number (STN) BL 103257/5066 has been assigned to your recent supplement to your biologics license application for Candida albicans Skin Test Antigen for Cellular Hypersensitivity, CANDIN®, dated April 5, 2016. Your submission is in the form of a “Supplement – Changes Being Effected” as described under 21 CFR 601.12(c)(5).

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February 04, 2022 at 08:11PM Allergenics Advisory Review Panel Reports

Allergenics Advisory Review Panel Reports

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February 04, 2022 at 06:01PM Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

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February 04, 2022 at 04:33PM Class II Special Controls Documents

This page lists special controls guidance and guideline documents developed by CDRH and other FDA Centers.

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February 04, 2022 at 03:53PM Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic

COVID-19

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February 03, 2022 at 07:25PM FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)

Procedural

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February 03, 2022 at 03:54PM Help Stop the Spread of Coronavirus and Protect Your Family

We can each take simple steps to slow the spread of COVID-19 and protect ourselves, our families and our communities. Get a COVID-19 vaccine. Wash your hands often. Cover your mouth and nose with a mask when around others. Avoid crowds and practice social distancing.

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February 03, 2022 at 03:45PM It’s a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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February 03, 2022 at 03:39PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.

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February 03, 2022 at 03:16PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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February 03, 2022 at 03:11PM RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases - 03/09/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a public webinar on Wednesday, March 9, 2022, from 11:00 a.m. - 12:00 p.m. ET.

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February 03, 2022 at 03:00PM Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format

Drug Labeling
OND

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February 03, 2022 at 03:00PM Population Pharmacokinetics

Clinical Pharmacology

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February 02, 2022 at 11:17PM Q&A for Comirnaty (COVID-19 Vaccine mRNA)

FDA conducted a thorough evaluation of the data and information submitted in the Biologics License Application (BLA) for Comirnaty before making a determination that the vaccine is safe and effective in preventing COVID-19 in individuals 16 years of age and older.

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February 02, 2022 at 09:08PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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February 02, 2022 at 07:22PM Q&A for Spikevax (COVID-19 Vaccine mRNA)

Q&A document with information about FDA's recent approval of Moderna's Spikevax (COVID-19 Vaccine, mRNA).

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February 02, 2022 at 01:42PM Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement - 02/15/2022

This the CBER Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement

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February 01, 2022 at 10:38PM Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

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February 01, 2022 at 08:16PM COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

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February 01, 2022 at 08:13PM Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Information Sheet Guidance
for Sponsors, Clinical Investigators, and IRBs

Frequently Asked Questions
Statement of Investigator
(Form FDA 1572) (Revision 1)


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February 01, 2022 at 08:07PM Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Biostatistics

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February 01, 2022 at 05:20PM Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency

Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency

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February 01, 2022 at 05:08PM Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

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