With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]
Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers. We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well. Most of us think […]
The FDA issued a guidance today that describes the what, when, and how (as well as other key elements) of its Competitive Generic Therapy (CGT) process. The CGT process was originated with the passage of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. The CGT provisions permit expediting review of ANDAs for products […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
Reports of Secretary Azar’s comments regarding not being able to assure affordability of vaccination for all is a sign of the times we live in now. Now, I agree that a pharmaceutical company that can develop a vaccine to this deadly virus should be compensated fairly, but, if the United States fails to assure the […]
Well, I am back from three weeks of traipsing around South America and ready to hit the blogging trail again. Thanks to all my Lachman colleagues who took up the charge and did a great job in my absence. However, while away, I tried to keep up by reading the trade press when I had […]
Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology | 3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It […]
Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect. A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”. Since the beginning of time, the Agency […]
As of the postings both on the FDA daily approvals list (here) and the FDA All Approvals List (here), the morning of December 3, 2019 OGD lists 49 full approval actions and 8 tentative approval actions for a total of 57 approval actions for month two of FY 2020. October has a final official approval […]
In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations. While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active […]
