Back in May 2016, we did an update on the number of first generic approvals over the last 3 and one partial fiscal year (FY) since GDUFA’s implementation (here). Well, last week, the Office of Generic Drugs (OGD) published its list of first-time generic approvals for the full 2016 FY and now we can update […]
FDA has announced that study data standards are required for clinical and nonclinical studies that are started after December 17, 2017. FDA notes that it may Refuse-to-File (RTF) NDAs and BLAs or Refuse-to-Receive ANDAs if the data does not conform to the standards outlined in the Guidance for Industry – Providing Regulatory Submissions In Electronic […]
Yesterday, OGD updated the final monthly statistics reported in the Activities Report of the Generic Drug program for FY 2016. While we had many of the activity numbers before, this final update provides additional information relevant to the program. September 2016 saw the fewest number of Refuse-to-Receive (RTR) actions (9) with a FY 2016 yearly […]
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 […]
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) […]
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 […]
