Tuesday, December 17, 2024

 On Monday, the FDA Office of Inspections and Investigations (OII) published a feature story titled, “FDA Office of Criminal Investigations Agents Catch Doctor Who Poisoned Patients with tainted IV Bags.” The feature story highlights the work conducted by the Office of Criminal Investigations that identified the suspect responsible for tampering with IV bags at Baylor Surgicare in North Dallas, TX.

 On Monday, the FDA’s Center for Veterinary Medicine issued a letter to veterinarians regarding its evaluation of adverse events reported in dogs of various ages treated with Librela (bedinvetmab injection). The adverse events identified and analyzed include ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events.

 

  • Today, the FDA posted four warning letters to companies for introducing unapproved GLP-1s, including semaglutide, tirzepatide and/or retatrutide products into interstate commerce. The letters were sent to: 

    The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1  products, including one that claims to be approved by FDA.

US FDA warns online vendors selling unapproved weight-loss drugs Story by Reuters

 US FDA warns online vendors selling unapproved weight-loss drugs

 

  • Trump Promises to Eliminate PBMs, Calling Them Overpaid …

  • The Trump Sequel: What to Expect on PBMs, 340B, Drug Pricing, …

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  • Trump targets PBMs in comments at Mar-a-Lago

     
  • Health Insurers Fall as Pfizer CEO Says Trump Wants PBM Reform

  • Thursday, December 12, 2024

    Wednesday, December 11, 2024

     

    Walgreens is reportedly in talks to sell itself to Sycamore Partners, exiting the public markets after significant financial struggles. The Wall Street Journal reported that a deal could come together quickly if talks proceed.

    Tuesday, December 3, 2024

    Tuesday, November 26, 2024

    Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding

     https://www.fda.gov/animal-veterinary/animal-drug-compounding/inspections-recalls-and-other-actions-respect-firms-engage-animal-drug-compounding

    Sep 20, 2024 — Referral Letter to Oklahoma State Board of Pharmacy Issued 02/2

     

    5 days ago — The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. The public will also have the option to ...

     

    5 days ago — NPR hits the GLP-1 nail on the head. A National Public Radio piece this week tackled the issue of compounded GLP-1 drugs and got the facts and nuance just right ...

     

    5 days ago — Any nonresident pharmacy or in-state compounding pharmacy without a license that dispenses prescription products into Massachusetts on or after May 1, 2025, ...

     

    6 hours ago — “None of these drugs are old enough yet to be generic. They're still all ... A compounded drug is a medicine pharmacies make from scratch. The FDA has ...

     

    5 days ago — ... to influence drug pricing, which he says could weaken FDA's ability to regulate compounded drugs and erode its authority over compounding pharmacies.

     

    2 days ago — ... drug from U.S. regulations that allow it to be compounded. The FDA said it ... compounded drugs are not tracked in traditional channels. Compounding ...

     

    3 days ago — FDA is in a quandary about compounding of the new obesity drugs, semaglutide and tirzepatide. The nominee to lead FDA has an interest.

     

    14 hours ago — However, there is controversy swirling around the FDA's recent decision on the drug shortage for GPL-1 obesity medications and the practice of compounding ...