ICH M12 Drug-Drug Interaction Studies Final Guidance - 10/09/2024
ICH M12 Drug-Drug Interaction Studies Final Guidance
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.
Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk
Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to
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
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.
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