ICH M12 Drug-Drug Interaction Studies Final Guidance - 10/09/2024
ICH M12 Drug-Drug Interaction Studies Final Guidance
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.
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
On August 19, 2024, the FDA approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanc
Submit an eCTD v4.0 or Standardized Data Sample to the FDA
Learn more about FDA's process to validate sample new eCTD v4.0 submissions and standardized study datasets.
Drug Trials Snapshots: ANKTIVA
ANKTIVA is a drug to activate the immune system used together with another drug called Bacillus Calmette-Guerin (BCG) to treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS).
Electronic Regulatory Submissions and Review Helpful Links
Electronic Regulatory Submissions and Review Helpful Links
Data Standards in the Drug Lifecycle
Uniform study data enables FDA scientists to explore many new questions by combining data from multiple studies.
Role of CDER in the Health Level Seven (HL7) Vulcan Accelerator
FDA is one of the founding members of one of the Health Level Seven (HL7) Accelerators’ program called Vulcan. Health Level Seven (HL7) is a standards developing organization aimed at providing a comp
Submit a Standardized Data Sample to FDA
FDA would like to assist sponsors and applicants who have not previously submitted an eCTD and/or standardized study data, and who are planning a submission to the FDA. We offer a process to validate
eCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0
FDA Roundup: August 16, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
FDA granted marketing authorization for the First To Know Syphilis Test, the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood.
iRhythm Technologies Inc. San Francisco, CA. 483 issued 07/31/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 07/31/2024 Short Title (70 char) iRhythm Technologies Inc. San Francisco, CA. 483 issued 07/31/2024 FEI Number 30072
August 16, 2024
FDA granted marketing authorization for the First To Know Syphilis Test, the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood.
FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer
On August 15, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after s
Drug Trials Snapshots: IQIRVO
Drug Trials Snapshots: IQIRVO is a agonist used to treat primary biliary cholangitis (PBC). It's prescribed with ursodeoxycholic acid (UDCA) for adults who don't respond well to UDCA alone, or as a st
FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.
The FDA has issued a warning letter to Austrofood and taken several steps to address concerns about elevated lead levels in cinnamon following an incident this fall associated with certain cinnamon apple sauce pouches.
FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods
FDA announces the issuance of draft guidance for Phase II of its voluntary sodium reduction targets as a next step in a data-driven, iterative approach to reduce sodium across the food supply.
August 15, 2024
FDA announces the issuance of draft guidance for Phase II of its voluntary sodium reduction targets as a next step in a data-driven, iterative approach to reduce sodium across the food supply.
Skip the Antibacterial Soap; Use Plain Soap and Water
There's no evidence that nonprescription antibacterial soaps are better at preventing illness than washing with plain soap and water. Some antibacterial ingredients can do more harm than good over the long-term.
FDA Roundup: August 13, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA notification regarding potassium phosphates injection
FDA requested a company stop distributing unapproved versions of potassium phosphates injection on August 1, 2024.
August 13, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.