Clinical Research Solutions
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....
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled “Pediatric Study Plans: Content of and Process for Submitting...
Clinical Research Solutions
Medical Product Communication, Part One: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer...
Clinical Research Solutions
Last Stop: President Obama – 21st Century Cures Bill Passes Through the Senate and Heads to Obama for Signature
After passing through the House of Representatives with an extraordinary amount of support last week, the 21st Century Cures Act headed to the Senate on Monday, December 5th. On Wednesday, December...
Clinical Research Solutions
#6: Expedited Programs for Serious Conditions – Drugs and Biologics
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an...
Clinical Research Solutions
#8: Special Protocol Assessment
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...