This morning I read Zach Brennan’s post on RAPS, titled FDA Smashes Record for Most ANDA Complete Responses Letters (CRLs) in One Year (here ). In his piece, he wrote: But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 […]
Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.” And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products. The FDA stated in its new release (here): This new plan includes several measures to help better communicate […]
The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday. August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017. These approvals are quite an accomplishment given the fact that the slowdown in […]
The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018. In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as […]
Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory. However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically […]
On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need […]
The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state). The FDA also estimates […]
The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ). This included […]
The GDUFA II reauthorization process involved a lot of agreements from the FDA. One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to […]
I know that the flag was raised in victory when the first generic of EpiPen was approved. Not many people outside those familiar with the plight of complex generic products could understand how or why it took so long for a generic version of that product to make it through the approval process. This is […]
