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September 30, 2020

BeSafeRx: Your Source for Online Pharmacy Information

Considering an online pharmacy? Have you or someone you know thought about buying prescription medicine online? FDA’s BeSafeRx campaign helps consumers learn about how to safely […]
September 30, 2020

Tonic Therapeutic Herb Shop & Elixir Bar – 610727 – 09/29/2020

Product: Drugs Recipient: Tonic Therapeutic Herb Shop & Elixir Bar 140 E German St.Shepherdstown, WV 25443United States [email protected] WARNING LETTER Date:               September 29, 2020 RE: […]
September 30, 2020

Alkermes, Inc. – 597260 – 12/02/2019

Product: Drugs Recipient: Recipient Name Richard F. Pops Recipient Title Chairman and Chief Executive Officer Alkermes, Inc. 852 Winter StreetWaltham, MA 02451United States Issuing Office: Center […]
September 29, 2020

Remarks by Dr. Hahn to the “Advancing Innovative Science in Generic Drug Development” Workshop – 09/29/2020

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration [embedded content] It is a pleasure to join […]
September 29, 2020

November 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement – 11/06/2020 – 11/06/2020

On This Page Date: November 6, 2020 Time: 10:00 AM – 4:00 PM ET Center Date Time Location CDER November 6, 2020 10 a.m. Eastern Time […]
September 29, 2020

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) – 11/19/2020 – 11/19/2020

On This Page Date: November 19, 2020 Time: 9:00 AM – 2:00 PM ET The Food and Drug Administration (FDA or Agency) is announcing a public […]
September 29, 2020

Panacea Biotec Limited – 607837 – 09/24/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Dr. Rajesh Jain Recipient Title Managing Director Panacea Biotec Limited B-1 Extn/A-27, Mohan Co-operative Industrial EstateMathura RoadNew […]
September 29, 2020

FDA Drug Topics: Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information – October 27, 2020

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs […]
September 29, 2020

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

Summary Company Announcement Date: April 30, 2019 FDA Publish Date: April 30, 2019 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Lack of […]
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