Clinical Research Solutions
On Friday, February 24th, FDA issued a press release stating that Endo Pharmaceuticals Inc. is recalling one lot of Edex® (alprostadil for injection) 10 mcg. What is Edex? Edex is a prescription only...
Clinical Research Solutions
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...
Clinical Research Solutions
On Tuesday, February 21st, the FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the Purple Book. What is the Purple Book? “The ‘Purple Book’...
Clinical Research Solutions
On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.” regarding its bioequivalence recommendations for the product. In the revised...
Clinical Research Solutions
In 2013, the FDA released a guidance entitled “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.” This guidance was finalized after...
Clinical Research Solutions
In the past two years, the FDA has approved two different types of intragastric balloon systems: Fluid-filled intragastric balloon systems, including the ReShape Integrated Dual Balloon System and...
Clinical Research Solutions
On Monday, February 6th, the FDA released the new process that will be used to collect and post curricula vitae (CVs) for advisory committee members. This will help FDA to post the appropriate CVs to...
Clinical Research Solutions
On Thursday, February 2nd, the FDA issued a safety announcement, warning consumers of rare but serious allergic reactions that have occurred with widely used skin antiseptic products containing...
Clinical Research Solutions
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Clinical Research Solutions
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...