Heads Up, Compounders!

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,

OTC Monograph User-Fee Comment Period Extended – Look at Comments So Far

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 a follow-up to the June 10,

Update of 2016 Activities Report of Generic Drug Program

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 two years (first years of GDUFA goals). 

CDRH Releases “General Wellness: Policy for Low Risk Devices”

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 $200 million had been invested in wearable start-up ventures.