September 30, 2023 at 06:00PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/Wpwzuso) to determ

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September 30, 2023 at 06:00PM General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manu

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September 29, 2023 at 07:03PM Minutes of Institutional Review Board (IRB) Meetings

Final FDA guidance for institutions and Institutional Review Boards on minutes of IRB meetings

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September 29, 2023 at 07:03PM Current Good Manufacturing Practice Requirements for Combination Products

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

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September 29, 2023 at 07:03PM CPG Sec. 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures (Obsolete, Withdrawn on 11/28/2017)

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September 29, 2023 at 07:03PM CPG Sec. 252.100 Source Plasma - Regulatory Action Based on Overbleeding (Obsolete, Withdrawn on 11/28/2017)

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September 29, 2023 at 07:03PM CPG Sec. 251.100 Schedule of Physical Examination for Donors Receiving Immunization Injections (Obsolete, Withdrawn on 11/28/2017)

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September 28, 2023 at 05:08PM Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs, biological products, therapeutic devices, and cell processing devices for the prevention or treatment

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September 28, 2023 at 03:09PM Electronic Submission Template for Medical Device De Novo Requests

This draft guidance introduces submitters of De Novo requests to CDRH and CBER the associated content to support De Novo electronic submissions to FDA.

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September 27, 2023 at 09:04PM COVID-19, Flu and RSV

COVID, Flu and RSV vaccines, tests, and treatments - information about FDA-approved and authorized medical products for seasonal respiratory illnesses

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September 27, 2023 at 06:21PM GLASSIA

Product approval information is indicated for treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin.

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September 26, 2023 at 09:45PM FDA Roundup: September 26, 2023

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

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September 26, 2023 at 08:16PM Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical

This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.

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September 26, 2023 at 05:42PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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September 26, 2023 at 02:53PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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September 25, 2023 at 06:01PM 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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September 22, 2023 at 10:12PM FDA Roundup: September 22, 2023

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

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September 22, 2023 at 07:19PM Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

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September 21, 2023 at 07:54PM Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop - 02/22/2024

This public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases.

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September 21, 2023 at 06:57PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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Live ‘Strike Force’ Recording and Steve Martin, Martin Short’s Las Vegas Shows Canceled Due to COVID - Hollywood Reporter

1. Live ‘Strike Force’ Recording and Steve Martin, Martin Short’s Las Vegas Shows Canceled Due to COVID  Hollywood Reporter
2. Jimmy Kimmel tests positive for Covid, cancels ‘Strike Force Three’ live show with Jimmy Fallon and Stephen Colbert  CNN
3. Jimmy Kimmel, Jimmy Fallon, Stephen Colbert Cancel ‘Strike Force Three’ Live Show as Kimmel Tests Positive for COVID  Variety
4. COVID CANCELATIONS: Multiple Las Vegas Events Scuttled by New Outbreak  Casino.Org News
5. Jimmy Kimmel, Stephen Colbert & Jimmy Fallon Cancel Strike Force Three Live Show In Las Vegas After ABC Host Gets Covid  Deadline
6. View Full Coverage on Google News

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September 19, 2023 at 10:22PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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September 19, 2023 at 09:38PM FDA Roundup: September 19, 2023

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

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September 19, 2023 at 08:49PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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September 19, 2023 at 04:52PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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September 19, 2023 at 03:21PM Kimera Labs, Inc. - 649343 - 09/01/2023

Investigational Device Exemptions (IDE)

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September 19, 2023 at 03:10PM FDA’s IT Strategy: Unlocking Potential, Leading Transformation

FDA has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission.

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September 18, 2023 at 09:28PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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September 18, 2023 at 01:39PM Human Biologics of Texas/Globus Medical - 557325 - 08/28/2023

Human Biologics of Texas/Globus Medical, Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak - Forbes

1. What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak  Forbes
2. What to know about Nipah virus outbreak in India’s Kerala state  The Washington Post
3. New Nipah outbreak in India brings high alert. How it began is not yet known : Goats and Soda  NPR
4. Top developments from Kerala today  The Hindu
5. Yet another virus alert  Hindustan Times
6. View Full Coverage on Google News

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What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak - Forbes

1. What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak  Forbes
2. What to know about Nipah virus outbreak in India’s Kerala state  The Washington Post
3. New Nipah outbreak in India brings high alert. How it began is not yet known : Goats and Soda  NPR
4. Top developments from Kerala today  The Hindu
5. Yet another virus alert  Hindustan Times

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September 15, 2023 at 08:35PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak - Forbes

1. What To Know About The Deadly Nipah Virus As India Races To Contain Outbreak  Forbes
2. India racing to contain deadly Nipah virus outbreak as hundreds are tested in Kerala state  Fox News
3. What to know about Nipah virus outbreak in India’s Kerala state  The Washington Post
4. Health Minister flags off mobile testing unit  The Hindu
5. Yet another virus alert  Hindustan Times
6. View Full Coverage on Google News

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September 15, 2023 at 03:43PM Section 8200: Investigational New Drugs (INDs)

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

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September 15, 2023 at 02:45PM Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)

Biosimilarity

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What to know about Nipah virus outbreak in India’s Kerala state - The Washington Post

1. What to know about Nipah virus outbreak in India’s Kerala state  The Washington Post
2. India racing to contain deadly Nipah virus outbreak as hundreds are tested in Kerala state  Fox News
3. Nipah trackers get samples from bats, trees as 800 tested in India’s Kerala  Al Jazeera English
4. Top Kerala News developments today  The Hindu
5. Express View: Checking Nipah  The Indian Express
6. View Full Coverage on Google News

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India's Nipah virus trackers gather samples from bats, fruit - Reuters India

1. India's Nipah virus trackers gather samples from bats, fruit  Reuters India
2. India racing to contain deadly Nipah virus outbreak as hundreds are tested in Kerala state  Fox News
3. Morning Digest | Central team of officials to visit Nipah-hit areas, Joe Biden’s son Hunter indicted on gun charges, and more  The Hindu
4. Health Minister flags off mobile testing unit  The Hindu
5. Nipah: Karnataka, Tamil Nadu must be alert, too  Deccan Herald
6. View Full Coverage on Google News

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September 14, 2023 at 03:12PM It’s a Good Time to Get Your Flu Vaccine

Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.

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September 12, 2023 at 09:54PM Breakthrough Devices Program

This guidance proposes select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health

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Nipah: What do we know about virus spreading in India's Kerala? - Reuters

1. Nipah: What do we know about virus spreading in India's Kerala?  Reuters
2. Indian authorities rush to contain a deadly Nipah virus outbreak in Kerala  CNN
3. Nipah trackers get samples from bats, trees as 800 tested in India’s Kerala  Al Jazeera English
4. Service of volunteer groups to those in home isolation: Veena  The Hindu
5. Unified approach: The Hindu Editorial on the Nipah outbreak in Kerala and a One Health approach  The Hindu

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Nipah virus outbreak in India: What you need to know about viral disease - Al Jazeera English

1. Nipah virus outbreak in India: What you need to know about viral disease  Al Jazeera English
2. Over 700 people tested for Nipah virus after two deaths in India  Reuters India
3. Kerala: India state on alert after Nipah virus deaths  BBC
4. Service of volunteer groups to those in home isolation: Veena  The Hindu
5. Unified approach: The Hindu Editorial on the Nipah outbreak in Kerala and a One Health approach  The Hindu
6. View Full Coverage on Google News

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September 13, 2023 at 09:34PM BIVIGAM

Product approval information is indicated for treatment of Primary Immunodeficiency Diseases (PIDD)

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Nipah virus outbreak in India: What you need to know about viral disease - Al Jazeera English

1. Nipah virus outbreak in India: What you need to know about viral disease  Al Jazeera English
2. India's Kerala shuts schools and offices to curb deadly Nipah virus  Reuters India
3. Karnataka District Issues Alert Following Nipah Cases In Kerala  NDTV
4. Service of volunteer groups to those in home isolation: Veena  The Hindu
5. India’s Kerala closes schools, banks in several villages after Nipah deaths  Al Jazeera English
6. View Full Coverage on Google News

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India’s Kerala closes schools, banks in several villages after Nipah deaths - Al Jazeera English

1. India’s Kerala closes schools, banks in several villages after Nipah deaths  Al Jazeera English
2. India's Kerala shuts schools and offices to curb deadly Nipah virus  Reuters India
3. Kerala: India state on alert after Nipah virus deaths  BBC
4. As Nipah Returns, How Kerala Plans To Prevent Its Spread  NDTV
5. Nipah outbreak | Online classes for students in Kozhikode’s containment zones  The Hindu
6. View Full Coverage on Google News

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FDA sends warning to CVS, Walgreens and other companies over unapproved eye products - CNN

1. FDA sends warning to CVS, Walgreens and other companies over unapproved eye products  CNN
2. FDA warns CVS, others against selling unapproved eye products  Reuters
3. FDA warns Walgreens, CVS over 'unapproved' eye drops  Crain's Chicago Business
4. FDA warns CVS, Walgreens and others about unapproved eye products  USA TODAY
5. CVS, Walgreens Warned Over Eyedrops After Deadly Bacterial Outbreak  Bloomberg
6. View Full Coverage on Google News

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September 12, 2023 at 08:40PM Bone Matrix Product: FDA Safety Communication - Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks

FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product.

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September 12, 2023 at 12:41PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

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September 11, 2023 at 11:06PM OTP Events, Meetings, and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

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September 11, 2023 at 12:47PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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September 11, 2023 at 04:11PM Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy

Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling.

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September 07, 2023 at 07:34PM COMIRNATY

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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September 08, 2023 at 11:47PM FDA Roundup: September 8 2023

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

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September 08, 2023 at 10:51PM Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research Real-World Evidence

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September 08, 2023 at 09:56PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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September 08, 2023 at 08:47PM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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September 08, 2023 at 06:54PM OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products - 08/30/2023

CBER and OTP is hosting its next virtual town hall on Wednesday, August 30, 2023 to answer stakeholder questions related to nonclinical assessment of cell and gene therapy products. Experts from OTP’s Office of Pharmacology/Toxicology will be on-hand to answer questions.

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September 08, 2023 at 06:49PM 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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September 07, 2023 at 10:01PM Albumin

Lists of the Albumin products.

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September 06, 2023 at 09:17PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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September 07, 2023 at 03:04PM Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

This guidance provides clarification and updated information on the use of ISO 10993-1 to support PMAs, HDEs, IDE Applications, 510(k)s, and De Novo requests.

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September 05, 2023 at 04:23PM Application of Human Factors Engineering Principles for Combination Products: Questions and Answers

Final Guidance for Industry and FDA Staff, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

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September 06, 2023 at 08:25PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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September 06, 2023 at 05:53PM Devices Guidances

This page lists Medical Device Guidance documents.

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September 06, 2023 at 03:17PM Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

This guidance proposes 4 best practices for choosing a predicate device to support a 510(k) submission.

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September 06, 2023 at 03:16PM Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.

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September 06, 2023 at 03:16PM Evidentiary Expectations for 510(k) Implant Devices

This guidance serves as a primary resource to provide clarity regarding expectations for performance data for implanted medical devices.

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