A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service.
Seems like every day we see new proposed legislation being introduced into another state’s legislature. Each one seems to have a somewhat different methodology or focus for controlling and reporting on drug prices. Let’s think about this. Everyone wants to strive for lower drug prices. Remember, in the early 1980’s, the entire nation was focused on reducing health care costs and the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act) came along to address drug prices and associated health care costs while providing additional protections for band name drug products.
On February 2, 2017 (here), we went out on a limb to suggest there may be an accurate method to track generic approvals throughout the month. We painstakingly tracked each daily report of the New and Generic Drug Approvals on the FDA web page for a month. We came up with 42 full approvals and 6 tentative approvals for January 2017.
The FDA issued a safety warning on Thursday afternoon regarding the potential for rare but serious adverse reactions (including anaphylaxis, hives and severe rash) for a common skin sanitizing agent. The warning focuses on chlorhexidine gluconate which is available both as a prescription and over-the-counter product for use as a skin sanitizer. In addition, the product is also available in an oral for use in gum disease products but those products already have the warning.
Remember the old FDA Monthly Approvals Report that never really provided numbers that matched the approvals that OGD reported in their Activities Report of the Generic Drug Program (Activities Report)? (see story here). We reported a usual 5-10% discrepancy relative to approvals between the reports. Well, the FDA Monthly Approval Report was discontinued many months ago,
Well, not naming any names- I really won’t come out and say who my pick would be, but, depending on the administration’s pick, this is a pretty crucial decision for the Agency. Here are some of the attributes I think would be important for the position:
- A knowledge of the FDA review and approval process
- A strong medical background
- A person that believes that science should rule the day
- Someone who is above the political fray
- A person that has both compassion and common sense
- Someone with an understanding of how the drug industry operated
Which of these attributes do I think is most important?
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 earth- there was disagreement among staff as the when such amendments required new patent certifications or little viii statement.
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 YES!if the method is as good as or better than the USP/NF provisions in a Monograph or in the General Chapters.
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,
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 an Annual Report,
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 Federal Register (FR) notice (here) issued today,
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 and the deciding factor will be that (as first explained in an old petition response to King Pharmaceuticals) “[i]n general,
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 is no longer marketed or removed from sale,
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 and answers that bring together FDA’s decisions on 180-day exclusivity that may have come from court cases,