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Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here).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 […]
In Southern California, May is noted as a month that sees a usual marine layer hanging over the coast. They call it “May Gray”. June is not much better and has the adopted the moniker of “June Gloom”. We often get sunshine later in the day, but most mornings are a combination of low clouds […]
I cringed while reading the opening two paragraphs of the article (here) written by Lawrence J. McQuillan in The Hill titled “How a reformed FDA can speed up delivery of lifesaving drugs”: The Biden administration favors a proposal to waive patent protections for the COVID-19 vaccines. But there are other ways to remove impediments to […]
For the last 5 or so years, the FDA has told applicants that they could likely submit an ANDA for a synthetic peptide product (40 amino acid chains or fewer) when the reference listed drug (RLD) was of rDNA origin but the guidance on which products, how, and what would be required was often sketchy. […]
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 […]
Well, our unofficial projections got the full approval actions right (at 55) but we missed one tentative approval action that was posted late (we reported 16) (here) but the official total reported here actually tallied 17 for a total of 72 approval actions for April 2021. 11 of the 55 full approvals were for first-time […]
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 […]
