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 However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]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Published a few days ago, the FDA draft guidance titled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (here) discusses the FDA’s thinking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 […]
In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]
With the demise of the Alzheimer’s drug aducanumab after the FDA’s accelerated approval and CMS’s actions to raise Medicare premiums in anticipation of huge demands based on its proposed pricing, we may now face another similar situation and that is with a drug for amyotrophic lateral sclerosis (ALS). After a 7-2 favorable vote by the […]
It appears that the OGD has hit a new high for total approval actions in August, judging by the unofficial numbers gathered from the available FDA databases as of this morning. Yes, that’s right-a total of ninety-five approval actions (seventy-four full-approval and twenty-one tentative-approval actions), which eclipses the ninety-four total full- and tentative-approval actions (eight-four […]
Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions. Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]
