May 20, 2021

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Summary Company Announcement Date: January 08, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company […]
May 20, 2021

ICH Q12: Implementation Considerations for FDA-Regulated Products

Submit Comments by 07/19/2021 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 […]
May 20, 2021

FDA approves nivolumab for resected esophageal or GEJ cancer

On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer […]
May 20, 2021

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 06/18/2021 – 06/18/2021

On This Page Date: June 18, 2021 Time: 9:30 AM – 11:30 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]
May 20, 2021

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar – 06/03/2021 – 06/03/2021

On This Page Date: June 3, 2021 Time: 1:00 PM – 2:00 PM ET ABOUT FDA will provide an overview of the Over-The-Counter Monograph Drug User […]
May 20, 2021

Drug Trial Snapshot: REVCOVI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 20, 2021

BGP, LLC – 613144 – 05/19/2021

Product: Drugs WARNING LETTER Date: May 19, 2021TO: [email protected] [email protected] – BGP, LLC2118 Wilshire Blvd #766Santa Monica, CA 90403 RE: Unapproved and Misbranded Products Related to […]
May 20, 2021

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Docket Number: FDA-2019-D-0934 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance represents FDA’s current thinking […]
May 19, 2021

FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments

FDA’s Clinical Methodologies Group (ClinMeth) within CDER’s Office of Medical Policy received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning […]
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