Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard S.
While there is not much new to report in the newly added numbers for certain metrics in the Activities Report of the Generic Drug Program for 2017 (here), there could be some raising of the eyebrows at the number of Complete Response Letters (CRL) issued in February (136), which is the lowest number issued for a given month in FY 2017,
Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application. That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications.
We all know how to reset the clock at daylight savings time (albeit the first morning we may find ourselves a bit behind or ahead). We all know how and when to change our watches when we cross time zones. FDA now needs to find out how to reset the clock on several ANDAs, and possibly a 505(b)(2) application,
It’s late, do you know where your data is? Are you really sure? Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval? If the answer to all the above questions is yes, congratulations! Unfortunately,
Once a vibrant means to bring various changes from a reference listed drug (RLD) to market, the ANDA suitability petition seems to have become the bottom of the totem pole, the last one in line, or a member of the forgotten world. As outlined under section 505(j)(2)(C) of the Federal Food Drug and Cosmetic Act,
Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews. Am I seeing this correctly? Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs negotiated for reauthorization and at the 11th hour,
OGD has revised its bioequivalence (BE) recommendation for rifaximin 200 mg and 550 mg tablets. Quite interestingly, the requirements for products that are qualitatively and quantitatively (Q1 & Q2) the same as the reference listed drug (RLD) will have a reduced burden and may eliminate conducting bioequivalence studies with clinical endpoints (albeit pharmacokinetic [PK] studies and in vitro testing will still be needed).
We don’t like to mention specific products in this blog, so let’s just say an FDA panel yesterday gave a less-than-stellar review of the benefits of an abuse deterrent product by stating that the benefits of a firms’ long-acting opioid pain reliever no longer outweighed its risk. A crushing blow to the product for certain.
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 U.S.
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 expensive if they are not taken,
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 big debate over the term describing the number of ANDAs OGD has in its court,