FDA has just updated the Activities Report of the Generic Drug Program with additional data from August 2016. FDA notes that it Refused-to-File 17 ANDAs in August, which is slightly below the average of 21/month so far this Fiscal Year (FY). OGD issued 167 Complete Response Letters (CRL) in August, above the monthly average of […]
According to a posting yesterday (here), the Office of Generic Drugs (OGD) approved 61 first-time generic products so far in 2016, with another quarter to go. When we look at the first approvals, there were multiple approvals for 10 products (so it appears that 51 different entities were approved (some of which may have been […]
FDA has been busy putting out new bioequivalence (BE) guidance documents and revising others. Under the new provisions of GDUFA II, the Office of Generic Drugs (OGD) will set a goal of issuing 90 product-specific BE Guidances at least 2 years prior to the earliest lawful approval date (here) of an innovator product. While this […]
FDA announced the fees for the Rare Pediatric Disease Priority Voucher and the Tropical Disease Priority Review Voucher in the Federal Register (here) and (here). These vouchers can be used to obtain priority review for another NDA or biologic application (BLA), or the vouchers can be sold to another sponsor to use as they see […]
After receiving thousands of comments on what the term “natural” should mean with regards to foods (see previous post here), the FDA is now reexamining the term “healthy” in food labeling. In addition, they also released an immediately effective guidance to describe their thoughts on their proposed enforcement discretion relative to the use of the […]
Well the negotiations for GDUFA II are completed, but what is in the works? This morning a Federal Register Notice (FR) published announcing a public meeting on GDUFA II, but the notice itself provides some insight to the changes coming in GDUFA II and some big changes are coming. The FDA plans to release its […]
Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA. This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish. The document also discusses which of the facilities, sites, […]
Often times proposed proprietary names go down to the approval wire, and sometimes there is last minute disappointment on behalf of at least one of the sponsors. For instance, when a proprietary name is cleared during the IND, NDA, or ANDA review, in the period between clearance and approval, there may be another applicant that […]
The FDA is holding a competition to develop an easy-to-use application that will connect overdose victims with carriers of naloxone in an effort to help a rapid, and hopefully, successful overdose treatment with the drug. This appears to be a different and unique kind of outreach program to help stem the tide of overdose deaths […]
OGD fully approved (AP) 51 ANDAs in August and tentatively approved (TA) 14 applications for a total of 65 approval actions for the month. Receipts of new original ANDAs was at 59 for the month, off of the monthly average of 72 (but remember, there were two big months that heightened that average). Straight line […]
