Wednesday, November 27, 2024

November 27, 2024 at 05:30PM FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)

FDA is investigating the known risk of hematologic malignancies with serious outcomes following Skysona, including those such as hospitalization, the requirement for allogeneic hematopoietic stem cell transplantation, and death - and is evaluating the need for further regulatory action.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/MgpEBt2

November 27, 2024 at 03:08PM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/LCsB5Ga

Tuesday, November 26, 2024

November 26, 2024 at 02:59PM Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products

This guidance provides recommendations to sponsors regarding measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/D6Isi8x

Monday, November 25, 2024

November 25, 2024 at 09:22PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/7WzbqYX

November 25, 2024 at 04:41PM Patient Listening Session Summaries

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/EUpeGVj

November 22, 2024 at 08:49PM FDA Roundup: November 22, 2024

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/lNHgpKk

November 22, 2024 at 03:19PM Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/8B1fc49

November 21, 2024 at 09:46PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/pxFVRkd

November 21, 2024 at 08:53PM FDA Patient Engagement Partnerships

FDA Patient Engagement Partnerships

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/6sbMLOZ

November 21, 2024 at 07:37PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/vgkS7qe

November 21, 2024 at 03:04PM Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice

For more than 30 years, OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products, arresting bad actors, and referring cases to the Department of Justice for prosecution.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/ieKwmfq

Wednesday, November 20, 2024

November 20, 2024 at 03:58PM Administrative Guidances

This page lists Administrative Guidance documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/YXdOflw

Tuesday, November 19, 2024

November 19, 2024 at 01:32PM 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.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/6URrFi8

Thursday, November 14, 2024

November 14, 2024 at 10:25PM CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices

Document issued on October 3, 2006 and supersedes Compliance Policy Guide (CPG) “Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)” that was issued in March 1995.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/39SA1eB

November 14, 2024 at 04:06PM Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/GJwID5Z

November 14, 2024 at 02:49PM FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency

FDA Approves Kebilidi, an adeno-associated virus vector-based gene therapy indicated for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/wjNzJVu

Wednesday, November 13, 2024

November 13, 2024 at 09:22PM WILATE

In adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/kjBVTbD

November 13, 2024 at 08:03PM eSubmitter Application History

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/MUvybXk

November 13, 2024 at 03:31PM About the FDA and How You Can Get Involved

About the FDA and How You Can Get Involved

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Uqfmg1D

Tuesday, November 12, 2024

November 12, 2024 at 09:21PM Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Guidance for Industry - Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, Procedural

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/iqe0FoI

November 12, 2024 at 08:19PM Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/tpo4XdL

Friday, November 8, 2024

November 04, 2024 at 02:26PM Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/k0nYuAa

November 08, 2024 at 10:36PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/rUTI7oP

November 08, 2024 at 09:05PM FDA Roundup: November 8, 2024

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/gkzCLBP

November 08, 2024 at 03:27PM Expanded Access to Experimental Biologics

Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtai

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/wDUsa5G

Thursday, November 7, 2024

November 07, 2024 at 03:08PM Influenza Virus Vaccine, Trivalent, Types A and B

List of Influenza Virus Vaccine, Trivalent, Types A and B products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3sJhND2

November 07, 2024 at 03:04PM Influenza Virus Vaccine, H5N1 (for National Stockpile)

For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/24fbJ5h

November 07, 2024 at 12:05PM Hepatitis B Vaccine (Recombinant)

List of Hepatitis B Vaccine (Recombinant)products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/JLaUs7B

November 07, 2024 at 12:02PM Hepatitis A Vaccine, Inactivated

List of Hepatitis A Vaccine, Inactivated products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/sV9gxMP

Wednesday, November 6, 2024

November 06, 2024 at 04:37PM Select CBER Projects and Activities

CBER projects and activities that address the 21st Century Cures Act and the Prescription Drug User Fees Act VI Reauthorization (PDUFA VI) as authorized by the FDA Reauthorization Act (FDARA)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/hDSQaWK

November 06, 2024 at 04:23PM CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/fuOUwPI

November 06, 2024 at 02:00PM Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/uv9LqNx

Tuesday, November 5, 2024

November 05, 2024 at 11:29PM FDA Roundup: November 5, 2024

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/ZPVUnym

November 05, 2024 at 08:26PM Vaccine Adverse Event Reporting System (VAERS) Questions and Answers

VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/fSvUXJj

November 05, 2024 at 03:43PM FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/VSUgzkb

November 05, 2024 at 03:00PM One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment

FDA collaborates with stakeholders across disciplines and sectors to promote the health of humans, animals, and the environment using science, technology, and innovation.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/e8EUKzj

November 05, 2024 at 02:44PM High-dose influenza vaccine appears better than standard-dose vaccines in preventing deaths from A(H3N2) influenza among older adults

High-dose influenza vaccine was more effective at preventing post-influenza deaths among elderly individuals during the 2012-2013 influenza season than standard-dose vaccines-- when the A(H3N2) influenza viruses were broadly circulating-- according to a study done by researchers at the U.S. Food and

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/tEpiX9j

Monday, November 4, 2024

November 04, 2024 at 02:33PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/UEKLFd8

November 04, 2024 at 02:26PM Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/GlYNKvJ

Friday, November 1, 2024

November 01, 2024 at 07:34PM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/smi852g

November 01, 2024 at 05:56PM Vaccines and Related Biological Products Advisory Committee September 20, 2024 Meeting Announcement - 09/20/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) September 20, 2024 Meeting announcement and meeting materials.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/obgPfty

November 01, 2024 at 01:55PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/tS94Bh1

November 01, 2024 at 01:50PM FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub

The Hub will act as the single point of engagement and connection with outside parties for drug and biological product development and represents a dynamic new model for cross-center collaboration at the agency.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/T41c3D0