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 ...

 

1 day ago — "These are powerful medications and right now a consumer can go on the internet and purchase them, even if it's not the right medication for them without any ...

 

2 days ago — Human drug compounding; FDA inspections; compounding recalls.

Trump’s pick to run FDA is top exec of company that provides compounded weight-loss drugs If confirmed as FDA commissioner, Makary would take the lead of the agency as it grapples with high-stakes policy issues that could impact Sesame’s business

https://www.statnews.com/2024/11/24/makary-sesame-compounded-weight-loss-drugs-semaglutide-fda-shortage-list/ 

 

 

FDA Approves First Generic Propofol Injectable Emulsion for Dogs

Today the U.S. Food and Drug Administration approved PropofolVet Multidose, the first generic propofol injectable emulsion for dogs. PropofolVet Multidose is approved for use as an injectable anesthetic in dogs.

PropofolVet Multidose contains the same active ingredient (propofol injectable emulsion) as the approved brand name drug product, PropoFlo 28, which was first approved on February 4, 2011. In addition, the FDA determined that PropofolVet Multidose contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

Read More Button

 The country’s largest PBMs—Express Scripts, Caremark and Optum Rx—are going on offense against the FTC, arguing in a new lawsuit that the agency's recent actions and administrative process subvert the Constitution, as Noah Tong reports.

 

Friday, November 22, 2024

 

PBMs strike back at FTC, claim administrative process is unconstitutional

By Noah Tong

Major PBMs are countersuing the Federal Trade Commission, claiming the agency is biased and has too much authority to upend the industry.https://www.fiercehealthcare.com/payers/pbms-strike-back-ftc-claim-administrative-process-unconstitutional?utm_medium=email&utm_source=nl&utm_campaign=HC-NL-FierceHealthcare&oly_enc_id=4679D3115845C1X

Tuesday, November 12, 2024

 

Submission of APC Comment Letter in Response to Eli Li

5 days ago — licensed compounding pharmacy or an illicit non-pharmacy entity – the company has declined to comment. So when Novo's CEO speaks of “compounded” drugs, one ...