Docket Number: FDA-2004-D-0241 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to sponsors […]

Reference #: NDA 212122 Product: Drugs Recipient: Recipient Name Inna Kissen, Ph.D. Recipient Title Senior Director, Promotional Regulatory Affairs AstraZeneca Pharmaceuticals LP 1800 Concord PikeWilmington, DE […]

Product: Drugs Recipient: Recipient Name Pascal Soriot Recipient Title Executive Director and Chief Executive Officer AstraZeneca Pharmaceuticals LP 1800 Concord PikeWilmington, DE 19850United States Issuing Office: […]

FDA’s Bad Ad Program is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to […]

Office of Prescription Drug Promotion Content current as of: 05/31/2024 Regulated Product(s)

FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) initiated the Support for clinical Trials Advancing Rare disease Therapeutics […]

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. This new law includes the […]

Clinical Trials: A Critical Part of Drug Development We celebrate Clinical Trials Day on May 20, in recognition of what is often considered the start of […]

EMAS Case Study The proposed study is a multisite, double-blind, randomized, placebo-controlled, parallel group study in children and adolescents with epilepsy with myoclonic-atonic seizures (EMAS). The […]