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 […]
After a disastrous start to the new year and the significant slowdown in approvals resulting from the OGD’s strict application of the provisions of the USP Elemental Impurity Chapter while awaiting harmonization with ICH Q3D, the approvals have begun flowing again. There are some changes in the final guidance (here) from the draft that the […]
The National Drug Code (NDC) number is a unique identifier for prescription drug products. The format, as explained by the FDA below, will need to be changed in the coming years to accommodate the entry of new labelers into the U.S. market. The advanced Federal Register Notice published today (here) outlines the issues and announces […]
With July in the books and the figures still being posted, we have great news to report. Thus far, as of this morning’s listing in the FDA’s “All Approvals” list (here), the OGD has racked up 97 full approvals (a monthly record by itself for full approvals) and 18 tentative approvals for a total 115 […]
On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”. This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller […]
