On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]
The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here. Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are […]
It has been more than a year-and-a-half since the FDA released its publication “An update to the Resiliency Roadmap for FDA Inspections.” Are you among the many companies wanting to stay current and who can benefit from some assistance in creating an executable year-to-year plan to maintain both long and short-term inspection proactivity? If so, […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and […]
The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024. BsUFA Fees The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]
The Agency announced today the first approval of a drug (Ycanth [cantharidin]) available for the treatment of molluscum contagiosum, a viral skin infection that is fairly contagious and is spread by direct skin-to-skin contact. It is approved for use for adults and pediatric patients two (2) years of age and older. However, most infections occur […]
With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]
REMOVING QUALITY ROADBLOCKS FOR CELL & GENE THERAPIES REGISTER HERE Keith Lamb, Executive Director, Lachman Consultant Services, Inc., will be joined by a panel of Cell & Gene Therapy (CGT) industry experts from leading organizations as they discuss the key considerations of successful CGT manufacturing and quality strategies. Roundtable topics will include: • Developing a […]
