FDA Adjusts Process Used to Collect & Post CVs of Advisory Committee Members
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...
FDA Warns of Rare but Serious Allergic Reactions Reported with Skin Antiseptic Products Containing Chlorhexidine Gluconate
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...
#3: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
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...
FDA Releases CDER’s 2017 Guidance Agenda
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...
FDA Extends Effective Date for its Refuse to Accept Policy for Premarket Tobacco Product Submissions
On August 8, 2016, the FDA issued a final rule outlining its refuse to accept policy for premarket tobacco product submissions failing to meet the minimum threshold of acceptability for FDA review....
FDA Warns of Elevated Levels in Belladonna in Various Homeopathic Teething Products
On Friday, January 27th, the FDA published a press release warning consumers of elevated levels of belladonna in certain homeopathic teething products. According to the announcement, an FDA-conducted...
FDA Bans US Import of Piston Syringes from Thailand Site
On Wednesday, January 25th, the FDA issued Import Alert 89-17, which banned the import of Nipro’s piston syringes (with luer lock tip or catheter tip) into the US from the company’s Thailand...
FDA Makes Critical Data Update to the Orange Book
On Wednesday, January 25th, the FDA unveiled a critical data update to Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.” According to the...
Medical Product Communication, Part Two: Medical Product Communications That are Consistent with the FDA-Required Labeling – Questions and Answers
After various industry professionals and stakeholders expressed an interest in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft...
#4: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled “Pediatric Study Plans: Content of and Process for Submitting...