Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens (https://www.fda.gov/media/162806/download) that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use. As I read the guidance a few things popped into my mind. How can one firm who owns […]
For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]
Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years. But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete […]
Just after we posted the blog about the other User Fee programs from the prepublication of the Federal Register, we receive an email from FDA indicating that the Fee Schedule was available, but there was a problem with the FR publication (here). Here are the new FY 2023 Generic Drug User Fees compared with the […]
The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022. However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]
As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.” This certainly applies for GDUFA III and in spades. Why? Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]
With only the September metrics left to round out the FY 2022 statistical report for the OGD, let’s take a look at the full official numbers for August. We also now have a good idea how FY 2022 will stack up against FY 2021, albeit a lot can happen in a few weeks as we await the […]
It’s no surprise that the use of generic drugs saves consumers and health plans big money. Now, add the savings being achieved from biosimilars (expected to increase significantly over the next year or two) and the amount is almost staggering! The just-released report, which can be found here, provides details that support the findings that […]
Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking on the standardization, proper format, and necessary information for the contents of these elements in OTC and prescription drug labeling. Right now, labeling for OTC products […]
The User Fee negotiations are still underway and those discussions must be finalized soon or you may not have many folks to speak to at FDA. Yes, there is some carryover money but no one knows for sure how employees will react if pink slips go out. It now looks like September 15th will be […]
