Medical device regulatory consultant Adrienne Lenz says FDA needs to develop a way for medical device manufacturers to transmit electronic 510(k) subm...
The Justice Department says Arthrex is paying $16 million to resolve a whistleblowers allegations of kickbacks leading to False Claims Act payments.
Federal Register news: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Dojolvi (triheptanoin).
Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Distribution Reports and Recordk...
Biogen says it is investigating the death of a 75-year-old patient who had taken the companys controversial Alzheimers drug Aduhelm (aducanumab).
FDA says research it funded demonstrated that in two contexts shorter courses of antibiotic treatment were as effective as longer courses, reducing th...
The Consumer Healthcare Product Association recommends four steps FDA should take in implementing an appeals court decision on regulating drug/device ...
FDA warns Adamson Analytical Laboratories about repeat CGMP violations in its work as a contract testing laboratory.