The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between […]

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]

The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. This update clarifies that a face-to-face […]

FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer 3/05/2024 Jubbonti and Wyost Denosumab-bbdz […]

Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) Good morning.  I’m delighted to be with you today and support your efforts to […]

Subscribe for email updates Recommended Acceptable Intake (AI) Limits and Testing Methods On 8/4/2023, FDA issued a final guidance on Recommended Acceptable Intake Limits for Nitrosamine […]

The following are common questions and answers about supply chain security requirements of the Drug Supply Chain Security Act. 1. Is the pedigree provision of the […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Jennifer C. Ellis Recipient Title President and CEO Cosmetic Specialty Labs, Inc. 210 SW Texas Ave.Lawton, […]

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Mohammed Saremi Recipient Title Chief Executive Officer Bell International Laboratories, Inc. 2950 Lexington Ave. S., […]