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September 29, 2020

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Summary Company Announcement Date: February 22, 2019 FDA Publish Date: February 22, 2019 Product Type: Drugs Prescription Drugs Reason for Announcement: Recall Reason Description Due to […]
September 29, 2020

The Center for Research on Complex Generics

On August 1, 2020 the FDA awarded a five-year grant to the University of Maryland and the University of Michigan to establish a Center for Research […]
September 28, 2020

NCTR Annual Reports

NCTR’s annual report summarizes the key accomplishments for each research division for the reported year. The report includes ongoing research project information, research collaboration highlights, and […]
September 28, 2020

FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices – 10/14/2020 – 10/14/2020

On This Page Date: October 14, 2020 Time: 8:00 AM – 5:00 PM ET Topics for Discussion Overview of Regulatory Process for Marketing and Licensing of […]
September 28, 2020

Is It a Cold or the Flu? Prevention, Symptoms, Treatments

Image Español Some of the symptoms of flu and COVID-19 are similar, so it may be hard to tell the difference between these contagious respiratory illnesses […]
September 28, 2020

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry

Docket Number: FDA-2020-D-1548 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to assist […]
September 28, 2020

M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers

Submit Comments by 11/27/2020 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 […]
September 25, 2020

Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2019-D-5743 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of Regulatory Affairs This guidance […]
September 25, 2020

Human Drug Imports

FDA protects public health by promoting supply chain integrity working to ensure medicines imported to the U.S. comply with applicable legal and regulatory requirements. Imported drugs […]
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