The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act. The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]
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 […]
In the past six (6) months, FDA has issued two (2) Alerts (here and here), for patients and caregivers to not use sterile products manufactured by the two companies cited in the alerts. One company compounds product for human patients, and the other for veterinarians and animals (pet owners, beware). In that same 6-month period, […]
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 […]
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 […]
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 […]
The FDA has published its guidance on Voluntary Recalls (here), revising the initial draft guidance issued April 24, 2019. The Agency notes that “[I]n addition to editorial changes made to improve clarity, changes from the draft to the final guidance include the addition of the terms correction and market withdrawal to the terminology section, the […]
Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]
