Synthetic Peptide Products Eligible for ANDA Submission – Maybe!

After years of internal FDA debate, the FDA issued a guidance yesterday which was designed to assist an ANDA applicant in “determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food,

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. 

Rare Pediatric Disease and Tropical Disease Priority Fees – Where the Air is Rare!

The voucher program for rare pediatric diseases and tropical diseases was established to encourage firms to develop drug products for both of these categories.  The voucher is awarded when such an NDA is approved, and that voucher can be used on another NDA by the same company or transferred (sold) to a third party to use on any other NDA products. 

Martin Shimer Reviews Patents and Exclusivity

In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with.

Patents are pretty straight forward,

Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to 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,

FDA Ducks Question of the Running of 3-Year Exclusivity In Digoxin Petition Response

On August 30, 2017, the FDA responded to three older petitions all submitted by the same law firm relative to Digoxin products.  See FDA’s full response here.  The petitions addressed three basic issues: 1) 3-year Hatch-Waxman exclusivity; 2) bioequivalence requirements for this narrow therapeutic index drug; and 3) dissolution and blend uniformity requirements. 

FDANEWS Webinar: Combination Products: Managing Design Controls

Featured Speaker

Ricki Chase, Director, Lachman Consultant Services Inc. Ms. Chase is former Director of the FDA Investigations Branch, where she was responsible for all operations including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase is an expert in implementation of food and drug law, compliance law,