Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right. At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter,
My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network. Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,
If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD.
The FDA today posted a revised draft guidance (here) on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II. We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.
Many in the industry have complained that with the stated purpose of the PFC to identify all facilities used in the proposed application the Agency could determine whether a facility inspection was needed.
While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement. It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs. These numbers may go up a bit if some stragglers show up when the numbers are scrubbed for the official totals.
Well after the first 5 years of GDUFA I, we now have a comparative look at all 5 years for various metrics reported by the FDA in their Activities Report of the Generic Drug Program. In the chart below the 5- year highs are bolded and some trends can be seen. For instance, the number of post CRL meetings was highest in year two of the GDUFA program.
Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees. The FDA published arrears lists today and there are a lot of folks on those lists. If there is an error or if you need to pay the fee you should either rectify the situation quickly or pay the owed fee.
On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II. There are a number of hidden landmines relative to fee payment, especially relative to the program fee and reminder information about requests to withdraw an ANDA and its impact on the tier designation for the Program Fee,
There has been a ton of news in the pharmaceutical world this week so I thought I would diverge from my usual posts to provide some brief sound bites of things that caught my interest and will hopefully catch yours.
First off, remember the New England Compounding Center (NECC) and the meningitis outbreak of 2012?
Now, I usually don’t try to second guess the FDA, and I certainly do not know much about the Center for Tobacco Products. In addition, I do not condone underage smoking, nor do I condone smoking at all and consider it one of the most significant threats to public health.
The complaint (here) seeks a fine of $279 for two violations of selling tobacco to a minor under the age of 18.
In a notice on the CDER webpage today, FDA published 32 new draft bioequivalence recommendation documents and revised 19 previously published recommendations. The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”.
The two DPI recommendations, one for salmeterol xinafoate and one for tiotropium bromide,
Got my NDAs and ANDAs a bit mixed up in this morning’s post (here) regarding potential first cycle approvals for ANDAs. The 8-month tentative approval for NDA 210064 was for a 505(b)(2) application and not an ANDA. Let’s give credit where credit is due to the New Drugs Review Division for that one.
In browsing the FDA generic approvals for October so far, there are some ANDA numbers that immediately caught my eye. ANDA 210064, which was tentatively approved on October 12, 2017, was, according to the tentative approval letter (here), received by FDA on December 16, 2016. That is an 8-month tentative approval.
We all are aware of the new fee schedule for GDUFA II which include:
- ANDA application
- DMF application
- Facility fees, both API and FDF
- ANDA holder fee
Timeline for payment of the fees for ANDAs is at the time of submission of the ANDA.
For those of you who read my blog post on September 13, 2017 (here), the new fee structure for NDA and certain BLAs may have come as quite a shock, especially if you don’t normally play in that sandbox. Well, apparently a lot of folks must have had questions too, as FDA just published a draft guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017: Guidance for Industry.”
It fully explains the new fee structure as to be derived 20% from application submissions and 80% from the program fees.