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, […]
ISPE presented the first in a series of planned annual events entitled, “The Women in Pharma” on Monday 19 September at its 2016 Annual Meeting. Key female pharmaceutical industry executives shared their stories at the morning session, focusing on the challenges and opportunities each embraced as they progressed though their careers. The session was led […]
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 […]
Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety. Companies are in a frenzy responding to regulatory citations and preparing for inspections. The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated […]
