“ And ... the leaders of the three major PBMs are facing heat from key lawmaker Rep. James Comer for their testimony during a hearing last month. Under scrutiny are statements made about PBMs relationships with local pharmacies, Paige Minemyer reports. - Heather Landi”
Thursday, August 22, 2024
Vet Comp Oncol . 2024 Aug 20. doi: 10.1111/vco.13003. Online ahead of print. Evaluation of the Amount of Compounded Chemotherapy Drugs: A Comparison Between Nine Compounding Pharmacies Samantha R Bajorek 1, Trina N Hazzah 1 2, John D Chretin 1 3, Tracy N Mills 4, Talon S McKee 4, Jennifer R Frank 5, Jessica L Benvin-Guzzo 6, Kary A Clifton 1, Philip J Bergman 4 6 Affiliations Expand PMID: 39164199 DOI: 10.1111/vco.13003
https://pubmed.ncbi.nlm.nih.gov/39164199/
| Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Intercos Europe S.p.A | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
Stepping stones and next steps: The first year of the Animal & Veterinary Innovation Agenda
Perspectives from CVM
In September 2023, the FDA unveiled our Animal and Veterinary Innovation Agenda to define our commitment to advancing human and animal health by supporting innovative products and approaches to real-world problems, prioritizing critical needs, streamlining and clarifying regulatory processes, and preparing the agency’s Center for Veterinary Medicine for the future. The Agenda describes some of the actions that we’re taking or proposing to take to help deliver the products that veterinarians, pet owners and animal producers need and to advance public health and sustainable food systems.
Since last fall, we’ve been busy initiating and continuing work on many of the key items described in the Agenda. I’m thrilled to share the progress we’ve made so far – and you can expect to see additional updates as we continue to evolve.
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Wednesday, August 14, 2024
| Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products | ||||
| Txsyn Int. LLC | Division of Human and Animal Food Operations West III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | ||||
| Nowrez & Ismail Shukri Company | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| BullyKamp Products LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Top Dog Pet Store LLC dba The Bulldog Cartel | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Baylab USA, LLC | OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | ||||
| Globus Medical, Inc. | Office of Medical Device and Radiological Health Division I | CGMP/QSR/Drug/Medical Devices/Adulterated | ||||
| LS Promotions Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Konrad Rejdak, M.D., Ph.D. | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program/IRB |
Thursday, August 8, 2024
FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs
The U.S. Food and Drug Administration today released a set of documents regarding the transition phase after the FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024.
To be legally marketed, an ingredient used in animal food (including pet food) must be the subject of an FDA-approved animal food additive petition (FAP) or be generally recognized as safe (GRAS) for the intended use in animal food. Under the MOU, the FDA has been providing scientific and technical assistance to AAFCO as they decide whether to include ingredients in the AAFCO Official Publication.
Although the MOU is expiring, AAFCO remains an important partner to the FDA. The FDA will continue to work closely with AAFCO and state regulatory partners to help ensure the safety of the animal food supply.
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