Tidbits from the AAM Fall Tech Meeting – Day 1 to Day 1.5

Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference.  Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view.  Here are some of the noteworthy tidbits:

  • What about those ANDAs that have had complete responses?

Do You Have a Story to Tell?

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,

Cook Gives State of OGD Report at AAM

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. 

FDA Heard You, But Did They Really Hear You?

The FDA today posted a revised draft guidance (here)  on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II.  We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.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. 

First Month of GDUFA II Looks Good for Approvals

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.

Final GDUFA I Activities Report Issues – How Does the 5-Years Look

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. 

Do You Owe the FDA Money?

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. 

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – A Must Read!

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,

More BE Guidances Issued and Revised

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,

CORRECTION – Please Note

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. 

Some Bright Spots on First Cycle Approvals

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.