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July 14, 2021

2021 FDA/PDA Joint Regulatory Conference – 09/27/2021 – 09/29/2021

On This Page Date: September 27 – 29, 2021 Time: 9:00 AM – 5:00 PM ET Location:       Virtual Background:Since 1991, the FDA/PDA Joint Regulatory Conference has […]
July 13, 2021

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance

Summary Company Announcement Date: July 12, 2021 FDA Publish Date: July 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility […]
July 13, 2021

Phoenix Nutritionals, Inc. – 613909 – 07/01/2021

Delivery Method: Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Mr. Kaleo Steven Whiting Recipient Title President Phoenix Nutritionals, Inc. 4727 Terrace DriveSan Diego, CA […]
July 13, 2021

CURE ID Moves to Automated Data Collection in Light of COVID Pandemic

By Heather Stone, MPH, FDA health science policy analyst, Center for Drug Evaluation and Research’s Office of Medical Policy In the race to find safe and effective treatments or […]
July 13, 2021

Dream Pharmacy 24/7 Enterprises Limited 2018 – 614898 – 07/01/2021

Product: Drugs Recipient: Dream Pharmacy 24/7 Enterprises Limited 2018 United States Issuing Office: Center for Drug Evaluation and Research United States DATE: July 1, 2021 WARNING […]
July 13, 2021

Guangzhou Minghui Cosmetics Co., Ltd. – 610575 – 07/06/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Biao Chen Recipient Title General Manager Guangzhou Minghui Cosmetics Co., Ltd. No. 1, Dongchang RoadDonghua Industrial […]
July 13, 2021

UPDATED TIME INFORMATION: July 15, 2021 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 07/15/2021 – 07/15/2021

On This Page Date: July 15, 2021 Time: 9:30 AM – 5:30 PM ET UPDATED INFORMATION (as of June 28, 2021): The meeting time has changed […]
July 13, 2021

January – March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity FDA is evaluating the need for regulatory action. Adlyxin (lixisenatide)Bydureon (exenatide)Bydureon BCise (exenatide)Byetta (exenatide)Ozempic (semaglutide)Rybelsus (semaglutide)Saxenda (liraglutide)Soliqua (insulin glargine and lixisenatide)Trulicity (dulaglutide)Victoza […]
July 13, 2021

2021_07 Test Article FT 01

Test one two three four five six seven eight.  Nine ten eleven. Content current as of: 07/12/2021 Regulated Product(s) Topic(s) Health Topic(s) Law(s) & Regulation(s)
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