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On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II.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

Compliance 360 – A podcast survival guide to US FDA enforcement and compliance

Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.

Compliance 360° is hosted by Medtech Insight

PODCAST LINEUP

October 23

Compliance 360° Part 10: Turn Your CMO Nightmare Into A Dream Come True (1 of 2)

June 5
Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?

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  The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”.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

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