Late Friday afternoon, OGD updated its reported metrics for the month of April. Below are the highlights of the new data that was reported. You can review the entire report on the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) For the third month in a row, OGD refused-to-file (RTR) 6 […]
For the first time this fiscal year (FY), it looks like the OGD will have taken fewer than 100 total final and tentative “approval actions” in a month. While we await the official OGD figures (which should be reported sometime next week), so far, for May, as gleaned from the FDA “All Approvals” page (here), […]
In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]
This is a song I have sung in my house for 48 years on June 11th but now I finally get some help from the federal government! The story was all over the news this week about how Americans waste a ton of money disposing of perfectly good food because of an arbitrary date. A […]
The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019. Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency. The […]
This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]
A podcast/article written by LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy, provides a description of the Competitive Generic Therapies program (which we have described previously here and here). Since we have covered the program in detail and there is an FDA draft Guidance available (here), we will not go […]
The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced. The increased level of detail and wider breadth of topics gives a […]
For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26, […]
In an interesting twist, a firm petitioned the FDA/DEA to request that a synthetic version of Cannabidiol (CBD) oil be placed in Schedule V of the Controlled Substances Act in order for the firm to submit an ANDA for a generic version of Epidiolex (a treatment for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome) […]
