• On Friday, the FDA announced it had conditionally approved the first torsemide animal drug for dogs. UpCard-CA1 (torsemide oral solution) was conditionally approved for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary edema (fluid build-up in lungs) in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

 On Friday, the FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis, under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

 

Update: FDA extends comment period for new regulations for animal drug labeling

On May 21, 2024, the FDA announced it is extending the comment period for the proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs” by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Either electronic or written comments must be submitted by August 9, 2024.

 Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period

May 22, 2024; 89 FR 44944

 

5/14/2024

05/03/2024

Natuzen Co., Ltd.

Center for Drug Evaluation and Research | CDER

CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	03/27/2024	Vintage Chemical Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	04/15/2024	Cohere Beauty	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated

 

05/14/2024	04/30/2024	Grupo Quimico SRL	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	04/30/2024	Washington Fertility Center	Division of Biological Products Operations I	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

 

05/14/2024	04/17/2024	Westwood Laboratories LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
05/14/2024	03/29/2024	Central Admixture Pharmacy Services, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Drug Products/Adulterated

 

05/21/2024	04/01/2024	Seatex, LLC	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
05/21/2024	04/30/2024	Akan Biosciences, Inc.	Office of Biological Products Operations – Division I	CGMP/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
05/21/2024	03/25/2024	Central Admixture Pharmacy Services, Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Drug Products/Adul

 

Specialty lab exec gets 10-year prison term for 11 deaths ...

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