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November 19, 2020

Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

Submit Comments by 01/19/2021 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 […]
November 19, 2020

Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry

Submit Comments by 01/19/2021 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 […]
November 18, 2020

Information for Industry | Drugs

About FDA About FDA and CDER CDER Ombudsman About FDA and CDER Doing Business With FDA About FDA and CDER CDER Exclusivity Board About FDA and […]
November 18, 2020

Public Notification: Vigorous Man contains hidden drug ingredient

[11-18-2020] The Food and Drug Administration is advising consumers not to purchase or use Vigorous Man, a product promoted for sexual enhancement. This product was identified […]
November 18, 2020

Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies – 06/09/2020 – 06/10/2020

On This Page Date: June 9 – 10, 2020 Day1: Tue, Jun 9 9:00 AM – 4:35 PM ET Day2: Wed, Jun 10 9:00 AM – […]
November 18, 2020

Public Notification: Livtone contains hidden drug ingredients

[11-18-2020] The Food and Drug Administration is advising consumers not to purchase or use Livtone, a product promoted for weight loss. This product was identified during […]
November 18, 2020

Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND

Docket Number: FDA-2010-D-0503 Issued by: Guidance Issuing Office Center for Food Safety and Applied Nutrition Center for Biologics Evaluation and Research Center for Drug Evaluation and […]
November 18, 2020

Activities Report of the Generic Drugs Program (FY 2020) Monthly Performance

GDUFA YEAR/Actions This Month 19-Oct 19-Nov 19-Dec 20-Jan 20-Feb 20-Mar 20-Apr 20-May 20-Jun 20-Jul 20-Aug 20-Sep FY-2020 Refuse to Receive (RTR) – Originals 1 3 4 […]
November 17, 2020

JG Atlas Comercios, SA de CV – 609415 – 11/06/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jonathan Alonzo Gonzalez Espinoza Recipient Title Chief Executive Officer JG Atlas Comercios, SA de CV Trueno […]
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