Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego agreed to pay the United States more than $33 million to resolve False Claims Act allegations that Alere knowingly…
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Source: The…
The FDA issued warning letters to five devicemakers, citing misbranding and significant quality deficiencies. Source: The GMP Letter
Health Canada announced that sterilant solutions and disinfectants to be used with medical devices are now classified as medical devices. Source: The GMP Letter
The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices. Source: The GMP Letter
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March…
The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing…
Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) prodded the White House to say what it’s doing to implement the 56 recommendations issued in November by the President’s Commission on…
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing…
None of the 10 largest U.S. drugmakers have lowered prescription drug prices as a result of the tax reform passed in 2017, according to an analysis from the office of…