Acthar Gel Synthetic (seractide acetate) injection, 80 units/mL and 40 units/mL, was the subject of NDA 017861, approved for Armour Pharmaceuticals on February 21, 1978, but was never marketed by the company. A Federal Register notice (here) announces the FDA’s determination that the product, that was ultimately withdrawn in 2014, due to failure to submit […]
While we usually cover drug- and device-related topics in this blog, something came swimming our way on an unrelated topic that I thought might pique your interest. I always thought that eating fish over red meat was a healthy choice. Well, that is still true, as long as you don’t eat too much. In a […]
In another generic drug Guidance issued in the beginning of the year, OGD Guidance tsunami, FDA has provided advice on how to decide what might be necessary to gain approval of an ANDA, where there is a drug-device patient interface. FDA notes throughout the Guidance that each ANDA will be evaluated on a case-by-case basis […]
On Friday, the FDA issued a draft Guidance entitled, “Referencing Approved Drug Products in ANDA Submissions” (here). The document describes what a reference listed drug (RLD) is, what an FDA reference standard (RS) is (a relatively new term with important distinctions from the RLD), and describes how the selection process should occur if the RLD […]
Like looking for something in the junk drawer in your house, you know it’s in there, but you really must rummage around to find it. The FDA issued its Guidance for Industry: 180-Day Exclusivity: Questions and Answers earlier this week and it is the junk drawer of 180-day exclusivity. It contains a compilation of questions […]
FDA issued the draft Guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities” (here) in late December 2016. FDA reminds us that, under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities (503B), and radiopharmaceuticals that are repackaged are subject to all applicable […]
In a previous blog, we postulated that the start of FY 2017 looked like the ANDA submission rate could be off to the races. We also speculated that December original new submissions might reflect firms’ end of year push to get applications into the Agency. We did not think we would see a submission number […]
FDA issued two new Guidance for Industry Documents late in 2016: (1) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here) and (2) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (here). These represent the 25th and 26th draft and/or final Guidances issued by FDA relating to pharmacy compounding. More will […]
FDA issued three new Guidance for Industry Documents late in 2016: (1) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here) ; (2) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here); and (3) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing facilities (here). These represent part […]
Previously in a blog post on November 21, 2016 (here) and again in a post on December 8, 2016 (here), we outlined the proposed GDUFA II program fee and the need to review the FDA spreadsheet in order to assure that affiliate firms are properly identified such that only one program fee is assessed in […]
