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April 22, 2020

Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval

Docket Number: FDA-2007-D-0150 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
April 22, 2020

Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry

Docket Number: FDA-2016-D-0412 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
April 22, 2020

Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 22, 2020

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

On April 22, 2020, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer […]
April 22, 2020

Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 – 09/25/2019 – 09/26/2019

On This Page Date: September 25 – 26, 2019 Time: 8:30 AM – 5:10 PM ET Location: Event Location The Hotelat the University of Maryland 7777 […]
April 22, 2020

Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019

Image View Recordings and Slides   Agenda This event is FREE and open to the public. FDA will discuss the latest developments in pharmaceutical quality and provide […]
April 22, 2020

Electronic Drug Registration and Listing Using CDER Direct – 10/22/2019 – 10/22/2019

On This Page Date: October 22, 2019 Time: 9:00 AM – 4:00 PM ET Location: Event Location The Hotelat the University of Maryland 7777 Baltimore Ave.College […]
April 22, 2020

Regulatory Education for Industry (REdI): 2019 CDER Prescription Drug Labeling Conference – Dec. 4-5, 2019 – 12/04/2019 – 12/05/2019

On This Page Date: December 4 – 5, 2019 Time: 8:00 AM – 5:00 PM ET Location: Event Location Attend Online orThe Hotel at the University […]
April 22, 2020

FDA Voices

Perspectives From FDA Leadership and Experts Content current as of: 04/22/2020 Regulated Product(s)
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