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Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here).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 […]
The Office of Generic Drugs (OGD) provided the final set of metrics to complete the March 2021. While many of the numbers are consistent with other months of this FY, there are a couple of surprise figures which we will cover, and will provide our commentary in an effort to try to explain them. There […]
The ANDA suitability petition process has been languishing for years. Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition. Today, I read […]
Do you ever wonder why the minutes of the PDUFA and GDUFA user-fee negotiation sessions are so scant? Minutes of one-hour meetings with the drug companies are typically two to five pages at the least, depending on the topics discussed. Transparency for the drug UFA negotiation meetings appears to be somewhat lacking (see previous post […]
On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management. Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]
There were numerous presenters in the morning session on April 28, 2021. Below are some of the highlights. Dr. Sally Choe, Director, Office of Generic Drugs (OGD) noted that OGD has prioritized assessment of over 50 ANDAs and more than 800 supplemental applications in FY 2021 to meet the needs associated with the Covid-19 pandemic. […]
