For a few days now, I have been scanning the FDA Monthly Approvals List (here) for November to keep up with the action at the Office of Generic Drugs (OGD). Searches for approvals for November on this site have come back with the following notice after the report was run – Your selected month and […]
FDA is finalizing its 2012 Proposed Rule and amending the regulations relative to certain Citizen Petitions. While the revisions mostly pertain to section 505(q) Petitions (originally created under the Food and Drug Administration Amendments Act of 2007 [FDAAA]), the Agency is (in at least one instance) broadening the mandatory certification requirements for certain Petitions. The […]
Millions of people suffer from occasional heartburn and take an Over-the-Counter (OTC) antacid, H2 blocker, or proton pump inhibitor to relieve the symptoms. But is that always the right thing to do? The FDA wants to make certain such products are properly used and that the public knows use of these OTC products are not […]
The Center for Veterinary Medicine has released a revised draft Guidance titled Animal Drug User Fees and Waivers and Reductions, which “describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions for such fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures […]
As you are well aware, the negotiations for GDUFA II have culminated in the release of the new GDUFA II Goal Letter and has improved (at least on paper) the chances for additional improvement in the speed of generic drug approvals. The initial overall baseline price tag for GDUFA II (starting on October 1, 2017) […]
The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me. Turns out that, if you are an ANDA applicant […]
Over the years I have been trying to convince firms that certain changes to approved ANDAs must always be filed as a Prior Approval Supplement (PAS) or, in some cases, these changes may be handled as a Comparability Protocol that is approved in an ANDA. At the GPhA Fall Technical Conference yesterday, Dr. Lucinda (Cindy) […]
The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”. With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major […]
There is no doubt that the Office of Generic Drugs (OGD) is receiving more work than it anticipated under the negotiated GDUFA I program. Dr. Kathleen (Cook) Uhl, Director OGD, noted that OGD received over 5 years of work in the first 4 years of GDUFA I, noting that the Agency anticipated receiving only about […]
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 […]
