Four Federal register notices published today announce the FY 2017 user fee rates for the Prescription Drug User Fee Act (here) , the Biosimilar User Fee Act (here), the Animal Drug User Fee Act (here) and the Animal Generic Drug User fee Act (here). PDUFA Fees for FY 2017 Biosimilar User Fees for FY 2017 […]
The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees. Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively. While the number of ANDAs submitted […]
The issue of sameness of labeling for generic drug products continues to be under scrutiny from both the innovator as well as the law bar. However, from a historical perspective, the concept of carving out certain provisions of labeling covered by exclusivity continues to be an area where the FDA has made only a few […]
Orphan Drug Designations (ODD) at the FDA has soared over the past few years with yearly jumps of 30% not uncommon. In a blog posted today on FDA’s website, Dr. Gayatri Rao, Director for the Office of Orphan Products Development (OOPD) notes that: “In 2014, we saw a 30% increase over the prior year’s record […]
Each week it seems that we read about FDA enforcement action on products marketed as dietary supplements, but are found to contain undeclared drugs without an approved NDA or ANDA. The striking thing is that these 30 products were the subject of enforcement action in the last month and a half. That means that from […]
The number of Controlled Correspondence (CC) sent to the Office of Generic Drugs (OGD) appears to be rising from year to year since the implementation of GDUFA (see chart below). The numbers in this table were derived from the Activities Report of the Generic Drug Program for the respective Fiscal Years so far under the […]
Ever since the forfeiture provision related to 180-day exclusivity as it relates to the requirement that firms receive approval or tentative approval within 30 months from receipt of an ANDA, there has been some industry confusion regarding the exception of a “change in requirements” and how that might toll the 30-month provision. Kurt Karst provides […]
Friday, FDA announced the first Rx to OTC switch for a topical retinoid to treat acne. Patients will soon be able to obtain Differin Gel 0.1%( the generic name of which is adaplene) as an OTC product in their local pharmacy or grocery store. Is this big news? I think so. Back in October 2013, […]
FDA issued a draft Guidance titled “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn” (here) describing how and what type of changes FDA anticipates ANDA applicants to make in such situations. FDA makes clear in the Guidance that it the Guidance does not have applicability to the FDA’s […]
Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products. The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially […]
