FDA says most postmarketing reports and commitments are generally progessing on schedule, according to the FY 2021 annual report.
The Government Accountability Office says a new HHS program to produce medical countermeasures such as drugs and vaccines should assess challenges and...
The Federal Trade Commission says GoodRx will pay a $1.5 million civil penalty for failing to tell consumers and others about the unauthorized disclos...
Attorney Amanda Johnston explains five steps FDA-regulated company executives can take to mitigate the risk of Park Doctrine violations.
FDA approves an expanded ventricular tachycardia indication for Abbotts FlexAbility catheter.
Federal Register notice: FDA issues debarment order against Sami Anwar that bars him from providing services related to an approved or pending drug pr...
Attorney Stephen McConnell explains how a recent court decision in a glucosamine supplement preemption case can be instructive to drug and medical dev...
FDA publishes the International Council on Harmonization M13A guidance on bioequivalence for immediate-release solid oral dosage forms.