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February 17, 2022

FDA approves treatment for anemia in adults with rare inherited disorder

Action FDA has approved Pyrukynd (mitapivat) tablets  to treat hemolytic anemia (a disorder in which red blood cells are destroyed faster than they can be made) […]
February 17, 2022

Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act – 03/22/2022

On This Page Date: March 22, 2022 Time: 9:30 AM – 12:30 PM ET The Food and Drug Administration (FDA) is hosting a public meeting entitled […]
February 16, 2022

FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray

February 16, 2022 Background FDA has become aware of safety reports involving compounded intranasal ketamine to treat psychiatric disorders which may be putting patients at risk. […]
February 16, 2022

TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene

Summary Company Announcement Date: February 16, 2022 FDA Publish Date: February 16, 2022 Product Type: CosmeticsDrugs Deodorant Reason for Announcement: Recall Reason Description Presence of benzene […]
February 15, 2022

Forms & Submission Requirements

FDA regulatory forms and application information Sub-Topic Paragraphs Content current as of: 02/15/2022 Regulated Product(s)
February 15, 2022

FY 2022 Generic Drug Science and Research Initiatives Public Workshop – 05/09/2022

On This Page Date: May 9 – 10, 2022 Day1: Mon, May 9 8:00 AM – 4:30 PM ET Day2: Tue, May 10 8:00 AM – […]
February 15, 2022

Indiana Chem-Port – 618173 – 02/02/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Hitendra Desai Recipient Title General Manager Indiana Chem-Port 349 GIDC Industrial EstateMakarpura, VadodaraGujaratIndia Issuing Office: Center […]
February 15, 2022

Crystal Clear Supplements – 620285 – 02/04/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER February 4, 2022 3211 SE Milwaukie […]
February 15, 2022

Pharmacy2Home/LandiCom Holding LTD – 615137 – 02/03/2022

Product: Drugs Recipient: Pharmacy2Home/LandiCom Holding LTD United States Issuing Office: Center for Drug Evaluation and Research | CDER United States FROM: The United States Food and […]
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