Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Biopreventative Company LLC dba Biopreventative 14508 Lincoln Blvd 121, #120Miami, FL 33176United […]

Speech by Grace Graham Deputy Commissioner for Policy, Legislation, and International Affairs – Food and Drug Administration Good afternoon. On behalf of the FDA, I am […]

Assessment in Support of Sentinel System Public Report  FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion […]

CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products. In the case of a generic […]

Antimicrobial Regulatory Science Research Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]

 Submit an annual report to FDA  Search the annual reporting database Annual Licensure Reporting Requirements Wholesale drug distributors and third-party logistics providers must be appropriately licensed […]