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June 2, 2020

LifeHealth Science – 599467 – 05/15/2020

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Bert Moyar Recipient Title Owner LifeHealth Science 1632 Enterprise Parkway, Suite FTwinsburg, OH 44087-2281United […]
June 2, 2020

Drug Safety and Risk Management Advisory Committee Charter

Authority The Drug Safety and Risk Management Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, […]
June 2, 2020

Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer

For Immediate Release: June 01, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. […]
June 1, 2020

Remarks by Commissioner Stephen Hahn, M.D. — The COVID-19 Pandemic — Finding Solutions, Applying Lessons Learned – 06/01/2020

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration The COVID-19 Pandemic — Finding Solutions, Applying Lessons […]
June 1, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020

For Immediate Release: June 01, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 1, 2020

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: May 29, 2020 FDA Publish Date: June 01, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of […]
June 1, 2020

FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions

[6/1/2020] FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow […]
June 1, 2020

Drug Trial Snapshot: GAMIFANT

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 […]
June 1, 2020

Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea – 08/21/2020 – 08/21/2020

On This Page Date: August 21, 2020 Time: 9:00 AM – 5:00 PM ET EVENT TITLE Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; […]
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