For years, the debate as to when an amendment to an ANDA or a 505(b)(2) application had to include a new patent certification raged on, and, at times, was handled on a case-by-case situation if it was noticed at all. Even when I was at the Agency – when dinosaurs walked the face of the […]
FDA published an updated Manual of Policy and Procedure (MaPP), 5310.7 after a 10-year first edition and this one (in my opinion) really clears up one of the age-old questions – can I cite a foreign compendia as the basis for establishing a specification or test method in my application? The answer is a resounding […]
No New Regulations – No New Hires – Will the Administration’s Actions Impact the Drug Approval Process?
Donald Trump signed an Executive Order freezing government hiring, except for the military, national security, or public safety personnel, and issued a memorandum placing a moratorium on any new regulations or Guidance. In addition, it is reported that the memorandum noted that if new regulations have been sent to the Federal Register, but yet unpublished, […]
FDA 2017 List of 101 Guidances – How Many Apply to Compounding Pharmacies and Are You Current and in Compliance???
For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation (procedures, policies, records, etc., in place and […]
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 A Federal Register notice (here) announces the FDA’s determination that the product, that was ultimately withdrawn in 2014, due to failure to submit […]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 […]
Good News/Not So Good News II? Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities
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 […]