Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great. We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen. We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions […]
We have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions. Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]
In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows. The discussion moves on to describe the new generation (well, not too new) of synthetic […]
Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease. One member said, when he resigned, that “this is the worst decision the FDA has ever made.” I get it. When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]
The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]
Well, it was May gray, as reported in our previous post (here),as OGD full approval actions plummeted in May to just 45, the lowest this fiscal year and all the way back to June 2019. Tentative approval actions projections for May are 13, bringing the total approval actions for May to 58. That is the […]
Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons: swelling of […]
In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]
Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development. Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.” This comes after several public […]
The FDA will publish a notice in the Federal Register tomorrow (May 13, 2021) that announces a notice of intent to scope out the need to issue an environmental impact statement relative to certain sunscreen active ingredients (namely oxybenzone and octinoxate) and their potential impact on the health of the coral reefs. This notice of […]
