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 […]
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 […]
The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016. We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents. Well, FDA has published another revised list and here are the changes: Comparative […]
As I dutifully read through this week’s Petitions and comments and Notices on regulations.gov, I came across a letter (here) telling FDA that the petitioner has responded to FDA requests and now the petition in over two years old and the petitioner wants FDA to expedite the review of its petition for an oral solution […]
After slogging through the 200+ pages of the Final Rule, here is a partial list of some of the comments I found interesting or that explain some of the changes or comments along with a summary of the FDA response from the Final Rule (here). Comment 9 – Clarification of importers requirement to identify every […]
The FDA announced in a safety warning today (here) that it was adding a Black Box Warning on all opioid and benzodiazepine products due to continued concern relative to potential fatal interactions and severe adverse events. The warning notes that the “FDA review has found that the growing combined use of opioid medicines with benzodiazepines […]
