NCTR’s annual report summarizes the key accomplishments for each research division for the reported year. The report includes ongoing research project information, research collaboration highlights, and […]

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 […]

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 […]

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 […]

1. Why are expiration dates important for consumers to pay attention to? Drug expiration dates reflect the time period during which the product is known to remain […]

The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing or conducting a clinical trial. They […]

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 […]

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 […]

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, […]