July was an amazing month for generic drug approvals with a total of 126 (ninety-six full approvals and thirty tentative approvals). We were wondering whether such a figure would be sustainable or whether it might empty the “ready-to-approve” bucket at OGD. We know the effort it takes to pump out that many applications and refill […]
The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons. Such determination is necessary to permit the continued marketing of other approved ANDAs that cite a Reference Listed Drug (RLD) as their basis […]
Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here). The document provides advice to sponsors of NDAs, ANDAs, some chemistry supplements, INDs, and manufacturers of non-application chewable products on the critical attributes that should be identified and quantified for chewable immediate release tablets. […]
In August 2018, the ICH Q11 Implementation Working Group (IWG) published training material in the form of a PowerPoint presentation for better clarification of ICH Q11 Questions & Answers – Selection & Justification of Starting Materials. The presentation can be found here: Q11 IWG – slide deck training material (choose “read only” option to view) […]
The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions. The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging. The FDA has always said that for most complex drug device products, the product […]
Well, after a couple of comments on my post (here) regarding timelines for resubmissions of MDAs, BLAs, and efficacy supplements, it came to my attention that this was an older MaPP. Sorry for the confusion but it came up as new on a daily feed I routinely review for blog material. Anyway, it certainly is […]
The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today. The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues. The document identifies resubmissions to NDAs, BLAs, and efficacy supplements […]
Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated. Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day. They say history repeats itself – no I am […]
First-time generic approvals are always good for the public and the industry. Through June, there were only 34 first approvals for the calendar year (an average of about 5.6 a month) and it looked like 2018 was going to be a slow year. Then came the July first‑time approval postings (here), where thirteen first-time generic […]
While we reported that July had already broken the previous approval record prior to the official July numbers being posted in an earlier post (here) we were happily shocked when the official approval numbers came out today (here). OGD fully approved a record 96 ANDAs (previous record was 88 in June FY 2017) and tentatively […]
