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 […]
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 […]
In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head. This was discussed […]
