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 […]
The FDA has published its guidance on Voluntary Recalls (here), revising the initial draft guidance issued April 24, 2019.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 The original draft guidance was issued on July 24, 2013.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 […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
Late Wednesday afternoon, the FDA posted official metrics for the items mentioned above. This was a p quick turnaround for these figures as they usually come out about the middle of the month. The OGD report (here) lists 61 full approval actions (we missed on our predictions by 1), which included 7 first generic approvals, […]
On February 2, 2022, I posted a blog on the Agency’s Guidance Agenda for 2022 (here) and chose seventeen of the ninety‑eight guidances listed that were my favorites for a number of reasons, but most of all due to what I felt was their significance. And, today, one of the guidances I had selected was […]
Sanitation Tunnels, as the name implies, are tunnels where a spray mist of antiseptic or disinfectant can be sprayed onto humans or animals. These tunnels, according to the FDA, were first employed in China and are being used in countries outside the United States to treat or prevent the spread of COVID‑19. The FDA further […]
In its “FDA Roundup: February 4, 2022,” the FDA announced that “on Feb. 2, the FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country.” The FDA says that it will continue to conduct mission‑critical foreign and domestic […]
