March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November. That’s the good news! The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]
The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation. The draft, along with other ICH guidances on validation and analytical procedures, can be found here. The draft revision of […]
The theme for the PDA annual meeting this year is “Agility in the New Normal.” The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.” He spoke about the intrinsic […]
Ever since I was an expert witness in one of the very first “pay-for-delay” cases back in the day, I have never understood how an arrangement that permits a drug to come to market well in advance of the expiration of a patent (and I am not talking about a weak patent that maybe never […]
After almost three months of calendar year 2022, the OGD is reporting twenty‑two first-time generic approvals. That seem like a whole lot but remember that if there are multiple first‑to‑file or first‑to‑approve ANDAs (which can sometime happen) for the same drug product, all of those that receive final approval on the same day are counted […]
In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here). The Agency notes that distribution from manufacturers to all outlets, which […]
First of all, Happy St. Patrick’s Day! The luck of the Irish prevailed last night as, one minute after midnight on March 17th, the Notre Dame Fighting Irish basketball team won its NCAA play-in game in double overtime for a chance to play #6 seed Alabama on Friday. I guess I have some luck too […]
For many drug products, determining the qualitative (Q1) and quantitative (Q2) formulation for purposes of establishing sameness of formulation to that of the innovator or reference-listed drug (RLD) product can be quite a chore. If you can get it right, then it may be possible to obtain a waiver of in vivo bioequivalence requirements for […]
The MHRA Good Clinical Practice Symposium was a virtual event this year due to COVID‑19. More than 800 individuals from over forty countries across the globe attended. Throughout the three‑day event, speakers provided their perspectives on clinical trials from their roles as inspectors, assessors, and reviewers representing the MHRA, FDA, and Health Canada. The agenda provided […]
On February 24, 2022, the Small Business and Industry Assistance (SBIA) group at the FDA hosted a webinar titled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (you can view the recording here). The goal was to describe the eight major changes to the August 2021 revision to the guidance Bioequivalence Studies […]
