In early August 2016, FDA issued a Guidance document for “Insanitary Conditions at Compounding Facilities” that states that under Section 501(a)(2)(A) of the FD&C Act that any drug prepared under insanitary conditions is adulterated. This document defines a drug as any compounded human or animal drugs; repackaged drug products; compounded or repackaged radiopharmaceuticals; and mixed, […]
In a pre-publication Federal Register Notice on Friday, August 5, 2016, FDA announced the reopening of the comment period on the issue of OTC Monograph User fees until October 6, 2016. In addition, the Notice indicated that the FDA “will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be […]
Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers. Some metrics have only been reported in the same context for the last […]
Take a look at the wrist of many individuals today and you will likely see a device monitoring physical activity. Whether it be a stand-alone device or one in the form of a watch which also facilitates telephone and text conversations, the business of personal wellness is growing. In 2014, Price Waterhouse estimated that over […]
There has been a lot of activity relative to inspection of outsourcing facilities (facilities that compound drug products under Section 503B of the Federal Food, Drug and Cosmetic Act). These facilities are held to cGMP standards and are subject to FDA inspection. Outsourcing facilities must be registered with the FDA and must pay a fee […]
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 integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance […]
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 […]
