The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018. Sponsors should expect to receive their invoices by August 29, 2018. This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15,
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 pipeline and get those approval packages lined up for the next month.
The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons.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 for submission,
Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here).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) .
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.
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 as either Class 1 or Class 2 submissions.
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 not planning to go back to FDA – but the same concepts and forces are in play today as they were when Hatch-Waxman (H-W) was first passed.
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),
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 approved 30 ANDAs (previous record was 23 in November 2017 (also in FY 2018) for a total 126 approval actions!
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 FDA made in the harmonization effort.
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 a public hearing on the topic.
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 approvals actions,
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 files in additional emails.
In a Federal Register notice today, the FDA announced the outsourcing FY 2019 fees (here) for regular and small business establishment fees and for the reinspection fee. FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019 and will be subject to establishment fees.