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 Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.
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,
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.
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.
OGD updated its Activities Report of the Generic Drug Program on Tuesday and there are not a lot of surprises to the updated numbers (we reported on the approvals, complete response letters, and receipts for August here.
Really the only things of interest appear to be the number of CBE supplements,
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,
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,
The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.
Compounders Outsourcing Fees FY 2018
* 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,
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.
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) ,
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,
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,
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,
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.
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,