As we mentioned in previous posts here and here, the new program fee to be instituted as part of GDUFA II and how much you have to pay may be dictated by your diligence in participation in the program fee clean-up currently underway at FDA. This process is designed to identify affiliates of firms, so […]
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. Hopefully, this […]
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 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 […]
In the past week, the news media reported on President Trump’s meeting with some leaders of big pharma and among the themes discussed were the lowering of drug prices, cutting regulation, speeding up drug approvals and bringing jobs back to the U.S. Previous postings have pointed out how the administration’s current freeze on Federal hiring […]
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 […]
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 […]
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 […]
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 […]
