August 31, 2023 at 08:13PM BECATS External User Guide-How to Enter a Certificate of a Pharmaceutical Product Application

This is the main page for How to Enter a Certificate of a Pharmaceutical Product (CPP) Application.

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August 30, 2023 at 02:02PM Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act

Procedural

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August 29, 2023 at 09:06PM FDA Roundup: August 29, 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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August 29, 2023 at 06:17PM 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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August 28, 2023 at 11:35PM CBER 2023 Orphan Approvals (new BLAs)

CBER Orphan Approvals for 2023

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August 28, 2023 at 11:35PM CBER 2022 Orphan Approvals (new BLAs)

CBER Orphan Approvals for 2022

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August 28, 2023 at 08:58PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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August 28, 2023 at 02:30PM 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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August 28, 2023 at 06:00AM CBER Orphan Approvals 2023

CBER Orphan Approvals 2023

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August 28, 2023 at 06:00AM CBER Rare Disease Program Frequently Asked Questions

CBER Rare Disease Program Frequently Asked Questions

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August 28, 2023 at 06:00AM CBER Orphan Approvals 2022

CBER Orphan Approvals 2022

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August 25, 2023 at 08:48PM ADYNOVATE

Product approval information is indicated for children and adults with hemophilia A (congenital factor VIII deficiency) 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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August 25, 2023 at 09:53PM FDA Roundup: August 25, 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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August 25, 2023 at 08:32PM Administrative Guidances

This page lists Administrative Guidance documents.

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August 24, 2023 at 08:05PM Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - 12/16/2022

The purpose of the public workshop is to discuss the impact of individual genetic heterogeneity on genome editing, and best practices for validating off-target editing events in the context of human genetic heterogeneity.

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August 24, 2023 at 06:31PM Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

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August 24, 2023 at 05:41PM ATGAM

Renal allograft rejection
Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation.
Limitations of Use:
The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates

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August 24, 2023 at 05:21PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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August 24, 2023 at 02:48PM Vaccines and Related Biological Products Advisory Committee Meeting October 5, 2023 Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting October 5, 2023 announcement and meeting materials.

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August 23, 2023 at 07:38PM VARIVAX (refrigerated and frozen formulations)

Product approval information for Varicella Virus Vaccine Live also known as Varivax.

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August 23, 2023 at 05:01PM Consumer Updates

Science-based health and safety information you can trust.

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August 22, 2023 at 03:36PM 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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August 21, 2023 at 11:31PM FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

FDA approves Abrysvo for immunization at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

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August 21, 2023 at 10:24PM Component of Erytype S

Product approval information is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system.

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August 21, 2023 at 07:56PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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August 21, 2023 at 07:09PM Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

This is the Draft Guidance for Industry, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

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August 21, 2023 at 03:09PM Clinical Guidances

This page lists Clinical Guidance documents.

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August 19, 2023 at 04:09AM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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August 17, 2023 at 10:29PM Human Cells, Tissues, and Cellular and Tissue-Based Products OMB Burden Statement

This is the Human Cells, Tissues, and Cellular and Tissue-Based Products OMB Burden Statement page

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August 14, 2023 at 07:40PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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Ice cream cups are recalled due to possible listeria outbreak. Here's what you need to know. - Yahoo Life

1. Ice cream cups are recalled due to possible listeria outbreak. Here's what you need to know.  Yahoo Life
2. Soft serve ice cream recalled due to listeria outbreak  CBS New York
3. Real Kosher Ice Cream Recalled in 19 States  Food & Wine
4. Ice cream recalled in nearly 20 states for Listeria contamination  Fox Business
5. Food safety alert: Mesa County Public Health issues alert after Listeria outbreak  KKCO
6. View Full Coverage on Google News

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Soft serve ice cream recalled in CT due to Listeria outbreak - CT Insider

1. Soft serve ice cream recalled in CT due to Listeria outbreak  CT Insider
2. Ice cream recalled after illness sends two consumers to the hospital; testing confirms Listeria contamination  Food Safety News
3. Hospitalization In PA Leads To Ice Cream Recall In 19 States: FDA  Daily Voice
4. Company Recalls Ice Cream Products Over Listeria Contamination Concerns  The New York Times
5. FDA recalls ice cream sold in Massachusetts due to Listeria concerns  Boston News, Weather, Sports | WHDH 7News
6. View Full Coverage on Google News

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Company Recalls Ice Cream Products Over Listeria Contamination Concerns - The New York Times

1. Company Recalls Ice Cream Products Over Listeria Contamination Concerns  The New York Times
2. Real Kosher Ice Cream Recalled in 19 States  Food & Wine
3. Soft serve ice cream recalled due to listeria outbreak  CBS New York
4. Ice cream cups are recalled due to possible listeria outbreak. Here's what you need to know.  Yahoo Life
5. Ice cream cups sold in 20 states linked to Listeria outbreak, CDC warns  Livescience.com
6. View Full Coverage on Google News

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August 11, 2023 at 09:43PM FDA Roundup: August 11, 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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Ice cream sold in 19 states is recalled due to listeria outbreak - CBS News

1. Ice cream sold in 19 states is recalled due to listeria outbreak  CBS News
2. Ice cream recalled in nearly 20 states for Listeria contamination  Fox Business
3. Real Kosher Ice Cream Recalled in 19 States  Food & Wine
4. Ice cream recalled after illness sends two consumers to the hospital; testing confirms Listeria contamination  Food Safety News
5. Ice cream sold in Ohio recalled for listeria  WJW FOX 8 News Cleveland
6. View Full Coverage on Google News

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Real Kosher Ice Cream recalled in 19 states for Listeria contamination - New York Post

1. Real Kosher Ice Cream recalled in 19 states for Listeria contamination  New York Post
2. Listeria outbreak may be connected to recalled ice cream cups, FDA says  CNN
3. Ice cream recalled after illness sends two consumers to the hospital; testing confirms Listeria contamination  Food Safety News
4. Ice cream sold in Ohio recalled for listeria  WJW FOX 8 News Cleveland
5. Ice cream sold in 19 states is recalled due to listeria outbreak  CBS News

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August 09, 2023 at 11:19PM OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 - 06/08/2023

This event will focus on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP, and will be a continuation of the December 2022 virtual town hall.

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August 08, 2023 at 10:29PM FDA Roundup: August 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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Montgomery police issue warrants after massive brawl on Alabama riverfront dock - CNN

1. Montgomery police issue warrants after massive brawl on Alabama riverfront dock  CNN
2. Montgomery brawl: Mayor says outbreak of violence is 'something that shouldn't have happened'  Yahoo News
3. WWE-Style Mayhem Caught On Camera: Punches Thrown, Hair Pulled, Chair Used  NDTV
4. Full Video: Viewer records as Montgomery riverfront brawl begins  WSFA
5. Johnson: Montgomery brawl defenders embody broader Black resolve, ‘Not today, y’all’  AL.com
6. View Full Coverage on Google News

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August 07, 2023 at 09:41PM VYJUVEK

Indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

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Severe thunderstorm outbreak with hurricane-force wind gusts expected for Eastern US - CNN

1. Severe thunderstorm outbreak with hurricane-force wind gusts expected for Eastern US  CNN
2. Severe Weather Outbreak Possible Across Eastern US With Destructive, Hurricane-Force Winds  FOX Weather
3. The Daily Weather Update from FOX Weather: DC, Philadelphia under threat of tornadoes Monday  Fox Weather
4. Powerful storms sweeping across the US  ABC News
5. Thousands of flights delayed as bad weather threatens Eastern US  CNN
6. View Full Coverage on Google News

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August 07, 2023 at 08:10PM 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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Tornado Watches in Effect as Severe Storms Forecast Across Eastern U.S. - The New York Times

1. Tornado Watches in Effect as Severe Storms Forecast Across Eastern U.S.  The New York Times
2. Severe Weather Outbreak Possible Across Eastern US With Destructive, Hurricane-Force Winds  FOX Weather
3. Severe thunderstorm outbreak with hurricane-force wind gusts possible for Eastern US  CNN
4. Severe Weather Outbreak To Produce Damaging Winds In East | Weather.com  The Weather Channel
5. Chicago weather: Monday starts drizzly, ends in upper 70s  FOX 32 Chicago
6. View Full Coverage on Google News

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Severe thunderstorm outbreak with hurricane-force wind gusts possible for Eastern US - CNN

1. Severe thunderstorm outbreak with hurricane-force wind gusts possible for Eastern US  CNN
2. Severe Weather Outbreak Possible Across Eastern US With Destructive, Hurricane-Force Winds  FOX Weather
3. Chicago weather: Monday starts drizzly, ends in upper 70s  FOX 32 Chicago
4. Sunday features a few storms; Monday features even more  WSET
5. Potential for severe weather Monday afternoon, evening | Weather | wfmz.com  69News WFMZ-TV
6. View Full Coverage on Google News

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August 07, 2023 at 04:50PM LANTIDRA

Product information for LANTIDRA

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August 04, 2023 at 07:11PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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August 03, 2023 at 09:22PM Premarket Approval (PMA) for CBER-Regulated Products

Center for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

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August 03, 2023 at 09:20PM Premarket Notification 510(k) Process for CBER-Regulated Products

CBER regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations.

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August 03, 2023 at 02:45PM Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

Procedural

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August 02, 2023 at 05:21PM Section 8200: Investigational New Drugs (INDs)

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

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August 02, 2023 at 03:19PM Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop - 03/30/2023

Immune Globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of Immune Globulins (IG).

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August 01, 2023 at 12:48PM 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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