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 […]
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. Qualified small business […]
A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019. And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years. The PDUFA total budget […]
The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees. The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting. The annual BPD fee is assessed the […]
Back in March 2018, we posted a blog that outlined the FDA actions to remove ANDAs for prescription PEG 3500 (brand Miralax) after a complete RX to OTC switch by the innovator was made. That post can be found here. The story is complex, and it took over 11 years to unfold, so if you […]
Today, in the Federal Register (here), the FDA announced the FY 2019 Generic Drug User Fees which include application fees, DMF fees and establishment fees for various types of facilities and program fees. While fees for most of the items showed only modest increases, the ANDA and DMF fees increased the most, at 4% and […]
