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 […]
Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives. Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]
The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms. The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]
The afternoon sessions of FDA’s Generic Drug Forum on April 28, 2021 were very information-intense and provided a significant amount of review information and suggestions for success in ANDA submission and approval. Caliope Sarago, Senior Regulatory Health Project Manager, Office of Research and Standards, Office of Generic Drugs, gave a comprehensive review of the pre-ANDA […]
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. […]
An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]
The FDA released its Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the second quarter of FY 2021 late yesterday. And there were not any real surprises. Y2021 First Quarter October – December Second Quarter January – March Third Quarter April – June Fourth quarter July – September ANDAs awaiting […]
As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post. Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]
