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January 21, 2025

Submit Your CDER Video Interview

Choose one of the following roles and start your interview: Pharmaceutical Scientist Physician Regulatory Health Project Manager Don’t see a role you are interested in? Submit […]
January 21, 2025

Video Interviewing With CDER

Welcome! You want to make a difference. FDA wants to hire you. The FDA Center for Drug Evaluation and Research (CDER) recruits candidates for open positions […]
January 21, 2025

Q&A on CGMP Requirements

As part of the Current Good Manufacturing Practice (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we […]
January 21, 2025

Advancing Product Quality

CDER is engaged in efforts to encourage drug manufacturing innovations and foster reliable manufacturing of high-quality drugs for U.S. patients and consumers. Emerging Technology Program In […]
January 21, 2025

Bioanalytical Method Validation for Biomarkers

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance helps sponsors of investigational new drug applications (INDs) and applicants […]
January 21, 2025

Abbott Laboratories – 669353 – 10/24/2023

Delivery Method: VIA UPS and Electronic Mail Product: BiologicsDietary SupplementsDrugs Recipient: Recipient Name Robert B. Ford Recipient Title CEO Abbott Laboratories 100 Abbott Park RoadAbbott Park, […]
January 21, 2025

2024 Recalls – Health Fraud

The list below provides information gathered from press announcements and other public notices about certain recalls of health fraud* – related products regulated by FDA. For […]
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