Proposed Rule to Save FDA Postage!
This is a first in a series of posts that will outline some of the more interesting and unique changes that the FDA is making in its Proposed Rule issued last week
371 Page Proposed Rule for Implementation of MMA ANDA and 505(b)(2) Provisions
Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.
22 ANDA Approvals in January – Or So We Think!
Well, it’s February 4, 2015 and the “Drug Approvals” page on the FDA website appears to have been updated to include ANDA approvals through January 30, and it substantially below the average approvals per month seen in the last two fiscal years.
FY 2015 First Quarter OGD Stats are Published – Picture is Not Rosy
Well, we now have the actual numbers for various input and output metrics for FY 2015’s 1st quarter that speaks to the current level of productivity at the Office of Generic Drugs (OGD). So, let’s look at some of the numbers.
Nexium First Generic Approved, 180-Day Exclusivity Issue Resolved?
I’m not quite sure what brought this long awaited generic approval to fruition but on January 26, 2015, the Office of Generic Drugs (OGD) issued approval for the product.
Coach K Gets 1000 Wins and FDA Gets Califf from Duke
Dr. Robert Califf was appointed FDA Deputy Commissioner for Medical Products and Tobacco. As such, Dr. Califf will oversee the “Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.”
So What’s Wrong with OGD Workload Reporting?
Lots! Here we are in mid-January, almost one-third of the way through the first GDUFA metric year and year three into the GDUFA program itself. As we have reported previously, CDER is having trouble with its new IT platform and, thus, reporting its statistics to the industry has been difficult at best and, at most, very confusing for anyone outside of FDA.
Uhl Named Permanent OGD Director
In what was a long-anticipated action, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) announced that Dr. Kathleen “Cook” Uhl will take over the reigns of the Office of Generic Drugs (OGD) on a permanent basis.
FDA Says Orally Disintegrating Ibuprofen is a No Go for an ANDA
On January 13, 2015, FDA denied an ANDA suitability petition requesting a change in dosage form from Ibuprofen Chewable Tablets, 100 mg to an Orally Disintegrating Tablet of the same strength. Anyway, FDA must have its reasons, and the Agency’s decision will stand unless the petitioner files a petition for reconsideration.
Office of Pharmaceutical Quality Standing on Own Two Feet
Well, it’s January 2015 and the Office of Pharmaceutical Quality (OPQ) is about to be stood up (“FDA speak” for official) and will be addressing quality issues across the New Drugs and Generic Drugs arenas. The concept is of one quality voice and one standard, but more about this in a bit. The new leaders of OPQ are outlined in a CDER posting relative to the new organization.
