Every year, FDA and key worldwide regulatory authorities perform foreign inspections of production facilities around the world. All inspections share a common goal: to ensure the products shipped to their respective countries will comply with the core requirements for safety, efficacy, quality, purity, and regulatory commitments. While foreign regulatory agencies merit respect, the FDA and […]
First of all, this is not a political blog. Second, I am certain that someone will still think it is. Third, in this case, I do not care as I am an ex-FDAer that truly believes in the Agency and wants to see it succeed. I was rooting for Scott’s nomination for many reasons, […]
After yesterday’s post (here), final numbers for February are out and, while good, it was not the jump we have hoped for. The total approvals for February, 61, were very close to the 60 reported on the New and Generic Drug Approvals site for the month. This is the lowest discrepancy seen in many months. […]
Almost every health-related headline today mentions costs. Whether it be cost of health insurance, cost of hospital stays, doctor’s charges, and (of course) cost of drugs. While there are some shockers out there for drug costs, most are in line with expectations. One of the big problems is that even moderately priced drugs are most […]
Irritation has been building between the Office of Generic Drugs (OGD) and industry over the use of the terms backlog vs. workload, particularly over the last few months. At the recent Annual Meeting of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association (GPhA), the semantics pot almost boiled over. So why the […]
The FDA published a recertification of its Manual of Policy and Procedure (MaPP) titled, “Good Review Practices”, MaPP 6025.1 yesterday. The first iteration of this document was issued in 2006. This is its second recertification. In reviewing the document, I was reminded of several calls and discussions I have recently had with my industry colleagues […]
In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date […]
The first two and a half months of calendar year 2017 saw the FDA approving 7 first-time generic products. The First Generic Approval reports are always good news for OGD, as these represent (in many cases) products that received priority review as first generics. It is also good news for consumers, as upon their […]
We are pleased to announce that Sharif Ahmed has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective February 20, 2017. Mr. Ahmed has been functioning as a Senior Associate in the Regulatory Practice at Lachman Consultants since January 2016. He is a seasoned Regulatory professional with nearly 30 years […]
Dr. Kathleen “Cook” Uhl, Director, Office of Generic Drugs told the story of the past, present, and future of GDUFA and how the industry and OGD are doing. Interestingly, she noted this was the first meeting she had attended where she heard that industry members said they are happy! Then she noted “you are not […]
