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.
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 Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.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,
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,
On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”. The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”
While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar.
The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014.
On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.
During the presentation, I was asked by one participant what I thought the maker of Opana ER would do.
As reported by FDA WebView (here [subscription required]), FDA announced the appointment of three former congressional staffers Dr. Gottlieb has chosen to add to his current team, as his team builds his vision for the Agency is becoming more clear. And it is not the usual vision we have seen from past commissioners.
This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara
If there’s something strange in your neighborhood; Who you gonna call? If there’s something weird, and it don’t look good; Who you gonna call? Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on in your neighborhood that’s holding up final ANDA (or 505(b)(2) NDA) approval.
Friday, FDA announced the first Rx to OTC switch for a topical retinoid to treat acne. Patients will soon be able to obtain Differin Gel 0.1%( the generic name of which is adaplene) as an OTC product in their local pharmacy or grocery store. Is this big news? I think so. Back in October 2013,
On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems. We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to fix their submissions if problems are found in the review,
FDA issued a revised bioequivalence recommendation for Lamotrigine ER Tablets calling on the firms to perform fasting and fed bioequivalence studies on the 200 mg tablet and a fasting study on the 50 mg. Neither of these products are the highest or lowest strength in the product strength range of 25 mg to 300 mg tablets.