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June 25, 2021

Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives – 07/12/2021 – 07/13/2021

On This Page Attend the workshop  Registration through Duke Margolis  Register In September 2020, the U.S. Food and Drug Administration announced a requirement that the Boxed […]
June 25, 2021

Sản phẩm của Vy & Tea chứa thành phần thuốc gây nguy cơ tiềm ẩn

English Version [2-26-2021] Cục Quản Lý Thực Phẩm và Dược Phẩm (FDA) khuyến cáo người tiêu dùng không nên mua hoặc sử dụng sản phẩm Vy […]
June 25, 2021

Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Submit Comments by 09/24/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
June 24, 2021

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to […]
June 24, 2021

FDA and Center for Research on Complex Generics Co-Hosted Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions – 08/18/2021 – 08/20/2021

On This Page Date: August 18 – 20, 2021 Day1: Wed, Aug 18 8:30 AM – 5:00 PM ET Day2: Thu, Aug 19 8:30 AM – […]
June 23, 2021

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 06/28/2021 – 06/28/2021

On This Page Date: June 28, 2021 Time: 2:00 PM – 4:00 PM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]
June 23, 2021

Remarks by Dr. Woodcock at the FDA FY 2021 Generic Drug Science and Research Initiatives Public Workshop – 06/23/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration (Remarks as prepared for delivery)  I am pleased to have […]
June 23, 2021

Pacific Center of Health/Pacific Center of Health & Acupuncture – 614526 – 06/22/2021

Product: Drugs Recipient: Recipient Name Richard Gold Pacific Center of Health/Pacific Center of Health & Acupuncture 8555 Aero Dr. Suite 107San Diego, CA 92123United States [email protected] […]
June 22, 2021

Las garrapatas y la enfermedad de Lyme: síntomas, tratamiento y prevención

[embedded content] English Las enfermedades transmitidas por las garrapatas, como la enfermedad de Lyme, están proliferando. Los casos reportados en los Estados Unidos aumentaron, de unos […]
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