A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s…

Looking back at FY 2023, CDER’s Office of Compliance’s recently issued annual report shows the office issued 170 human drug warning letters and classified 264 recalls affecting 1,178 drugs. Source:…

Vertex announced FDA approval of Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. Source: Drug Industry…

After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its…

Recently introduced bicameral, bipartisan legislation could make it easier for competitors to enter the generic and biosimilar market by putting controls on patent thickets created by pharmaceutical companies. Source: Drug…

Delving into the development of AI in healthcare, Google researchers have penned an analysis of how AI has grown from a mere concept in the 1950s to be a dominant…

Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by…

The Jan. 5 FDA announcement of its authorization of Florida’s program to import prescription drugs from Canada isn’t what it seems. Source: Drug Industry Daily

This edition of Quick Notes includes coverage of a cloth vest/halter that continuously monitors blood pressure, a Mayo Clinic deal on a newly cleared breast tumor 3D modeling device, and…

The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Source: Drug Industry Daily