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On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II.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,

FDA’s Center for Tobacco Products Seeks $279 Fine in Complaint

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. 

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  The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”.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. 

PDUFA VI Fee Changes – A Guidance to Explain the New Structure

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   Well, apparently a lot of folks must have had questions too, as FDA just published a draft guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017:  Guidance for Industry.”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.

Draft Guide on Reconsiderations at the Division Level Provide Process for Certain GDUFA Disagreements

I disagree with FDA – how many times have you said that, but did not act because, 1) you did not know who to call, or 2) you just did not know the process?  Under the GDUFA II program, there is actually a provision for reconsideration outlined in the GDUFA II Goal Letter (and if you have not heard this a thousand times – READ THE GOAL LETTER). 

New MaPP – Shuts Door on ANDA Review Status Requests from Other than Authorized Representative

The Office of Generic Drugs (OGD) has long taken the position that calls from multiple industry representatives about the same application to different OGD review staff or senior staff do nothing but waste the time of OGD.  This is definitely accurate; however, those multiple calls in the past were made because information was difficult (if not impossible) to get,

Final FY 2017 ANDA Numbers Are In – Holy Cow!

The FDA posted its final approvals and receipts numbers for FY 2017 today.  We thought there might be a blip in receipts due to firms trying to beat the GDUFA II fee clock which took effect on October 1, 2017, and we were right.  OGD received a whopping 202 ANDAs in September.  This was not a record month in FY 2017,

Major and Minor Amendments Under GDUFA II – Read Me Loud and Clear

The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements.  The system for classifying the goal dates has been simplified from a tiered system under GDUFA I to a standard and priority review system under the new GDUFA iteration.

RTR a New Q&A Guidance!

OGD has released a new Q&A document relative to refuse-to-receive issues.  I must be quite frank, there were some questions and their answers of which I was not aware.  Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.