Back in December 2013, I wrote a blog about antibacterial hand soaps (here) that still rings true today after the announcement of a superbug that is resistant to all antibiotics. In that post I wrote: “For years, we have heard scientists voice their concern relative to the widespread use of antimicrobial in the home and […]
Is there a reason to believe that the emergency contraceptive levonorgestrel (LNG), most popularly known as Plan B, may not be as effective in women that weigh more than 165 pounds or have a body mass index > 25kg/m2? According to FDA in a Question and Answers document (here) posted on the Center for Drug […]
There are obviously two schools of thought on the Proposed Rule that would permit generic companies to unilaterally update their labeling to include new safety information. On the consumer advocacy side, and from FDA’s view, it will improve patient safety (but personally I don’t see how). But when you look at the Proposed Rule (as […]
On June 6-8 at the Bethesda North Marriott Hotel, ISPE will be hosting the 4th annual Quality Manufacturing Conference, in collaboration with FDA and PQRI. Lachman Consultants is the sponsor of the Welcome Reception as well as the conference badges. In addition, we will be exhibiting in the hall at table 3. Please stop by […]
In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products. This information was taken from OGD’s Generic Approval reports (here) and navigating to 2013’s First-Time list (here). […]
The debate about whether prenatal vitamins are a medical food seems to have been clearly addressed once and for all in a revised Question and Answers Guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition” (here). Among other issues addressed in the Q&A document, FDA clearly states its position that prenatal vitamins are not […]
I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle. But I think I’ve got it now, and I hope I am right! The way the “backlog” used to […]
We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?
In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process. FDA notes that, while overall aspects of the drug, biologics and device review process […]
The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016. The two higher months were December 2015 (180) and March 2016 (114). OGD has received a total of 527 ANDA or an average of just a little over […]
