Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants. Remember that the answers […]
The use of novel excipients has potential to assist in the development of better final drug-product formulations for patients. However, drug-product manufacturers are hesitant to use novel excipients in product development because of the uncertainty of the expectations of the FDA and, ultimately, on the FDA’s acceptance of the new excipients in its development program. […]
The metrics for June appear to be in line with those of other months this FY. There were no big surprises. Here are some of the highlights. The OGD issued only three Refuse-to-Receive (RTR) letters in June, with one for a standard ANDA submission and two for priority submissions. It still seems that priority submissions […]
As of the posting on September 3, 2021, the FDA’s “All Approvals” database (here) listed fifty-five full‑approval actions and eight tentative-approval actions for August. While we know that these numbers can creep up with a couple of stragglers being reported a bit late, the good news is that the OGD hit a total of at […]
The Competitive Generic Therapy (CGT) program, which began in 2017 as a means to bring generics for products that had inadequate competition to market faster, has hit (and actually surpassed) the century mark in terms of the number of approvals. As the FDA notes in its announcement today, the authority for the program comes from […]
We have all seen the FDA announcements about the use of Ivermectin, a drug approved to treat worms in humans and animals (and not to treat COVID), and you have likely seen the now infamous FDA tweet “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Yet people are continuing […]
Today, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself. The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]
Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here). This 42‑page guidance supersedes the December 2013 draft guidance of the same name. The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]
Well, not only were we close, but we also hit the approval numbers for July on the head with 46 approvals and nine tentative approvals. While we reported 47 approval actions in our August 5, 2021 post (here), there was one July approval for a product with two strengths that are separately reported as approval […]
After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. So, this ends the announcements for the 2022 UFAs and you can take that to the bank! The new PDUFA […]
