by Samme Jancin | Jul 7, 2015
On June 30th, the US Food and Drug Administration (FDA) announced the intent to exempt 120 medical device classes with the goal to make it easier for companies to market devices. These devices will be exempt from the review requirements and premarket notifications...
by Samme Jancin | Jul 7, 2015
On July 1st, FDA announced its plans to focus on eight conditions under its Patient-Focused Drug Development (PFDD) Program in 2016-2017. Of these eight conditions, one of them is Autism, an autoimmune disorder. The PFDD is part of the Prescription Drug User Fee Act...
by Samme Jancin | Jul 1, 2015
On June 30th, the US Food and Drug Administration (FDA) gave pharmacies a four-month extension to comply with the track and trace policy. This track and trace policy was original created in 2013 under the Drug Quality and Security Act (DQSA). Under the DQSA, was the...
by Samme Jancin | Jul 1, 2015
After some of the most famous medical outbreaks have occurred in recent years, FDA has determined that not all surgical protective apparel is equal. FDA recently published a “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care...
by Samme Jancin | Jul 1, 2015
On June 29th, FDA made new recommendations on a previous draft guidance called “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The new proposals are intended to make it easier to manufacture generic popular drugs. Some of the...
