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  The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”.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   Well, apparently a lot of folks must have had questions too, as FDA just published a draft guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017:  Guidance for Industry.”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). 

MaPP Clarifies How OGD will Communicate Deficiencies Found in Initial Filing Review

Don’t need to get out your GPS because MaPP 5220.3 will help you understand how OGD plans to navigate the filing review to communicate major and minor deficiencies to the applicant in an information request (IR).  If the minor deficiencies can be resolved within a 7-day period, then your ANDA has the chance to be received on the original submission date. 

FDA Announces Outsourcing Compounders Fees

The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.

Compounders Outsourcing Fees FY 2018

Establishment

Small Business*

$5,364

Non-Small Business

$17,364

Re-inspection Fee

$16,093

* To qualify revenue must be less than $1,000,000 for all sites and affiliates

The Notice states that “FY 2018 registration period for outsourcing facilities starts on October 1,

Shame Letters from FDA- Will They Work?

The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.”

Many of these drugs are provided to patients through restricted distribution programs in which the drugs are sent from a specialty pharmacy directly to the patient. 

PDUFA VI Fee Structure and Fees Announced – Gulp!

In a Federal Register (FR) notice published today (here), the FDA announced that the base amount for the prescription drug user fee (PDUFA) program for new drugs would be $878,590,000, plus another $22,415,658 from something called the “capacity planning adjustment”, which is based on the elements the Agency is using to calculate costs (see list below) ,

Will September Bring a Rush of ANDAs?

Remember when GDUFA I first started and there was a huge number of ANDAs submitted prior to the October 1 implementation date to avoid paying the ANDA fee?  Remember when OGD changed its stability requirement in June 2014 and there were 635 ANDAs submitted prior to the implementation of the new stability requirements?  Well, October 1,

Official August ANDA Approvals and Receipts Reported

We were close with our September 6th post (guess) but there were a few more approval actions reported in the official statistics that were released Friday September 8 in the afternoon.  OGD approved 60 ANDAs and tentatively approved 17 ANDAs for a total approvals action of 77.  There was also a spike in Complete Response Letters (CRLS) where OGD reported the issuance of 155 CRLs,

August Unofficial Approval Figures Not What Industry Had Hoped 

 

Looking at the FDA’s “All Approvals” list (here)  and slugging through supplements and originals for both ANDAs and NDAs, it looks like OGD efforts in August will yield about 57 approvals (the 7th lowest so far in the first 11 months of FY 2017). Also, though OGD tentatively approved (what looks to be like) 16 ANDAs for a total approvals action of 73,

OGD Delivers on First of Two Documents – Early!

Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here.

The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types of deficiencies that will result in an RTR action,