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Human Drugs

Webinar on Drug QT/Proarrhythmic Risk Assessments

FDA announces a two-day (10/15-16) public Webinar on New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.

Medical Devices

High-Risk Groups Should Avoid Amalgam Fillings: FDA

FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible.

Human Drugs

Safety Alert on Benadryl Overdoses

Prompted by TikTok-posted teenager challenges, a new FDA safety alert warns that taking higher than recommended doses of Benadryl (diphenhydramine) ca...

Human Drugs

Leap Therapeutics Fast Track for Gastric Cancer Drug

FDA grants Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroesophageal junction a...

Medical Devices

$60 Million Surgical Mesh Agreement with 49 States

A coalition of 49 state attorneys general reach agreement that requires C.R. Bard and its parent company, Becton, Dickinson, to pay $60 million for th...

Gilead Paying $97 Million in Letairis False Claims Case

The Justice Department says Gilead is paying $97 million to resolve charges it illegally used a foundation to pay Medicare patients copays for the com...

Human Drugs

Final Rule, Guidance Issue on Drug Importation

FDA and HHS announce a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensur...

Human Drugs

Novartis to Start AVXS-101 IT Confirmatory Study

Novartis Gene Therapies says it will conduct an FDA-recommended pivotal confirmatory study of its AVXS-101 intrathecal formulation in older patients w...

Human Drugs

Court Says Private Plaintiffs Cant Second-Guess FDA

Attorney James Beck says defense attorneys in FDA preemption cases would benefit from reading a recent North Carolina federal court decision that uphe...

Federal Register

Info Collection on Genetic/Genomic-Based IVDs

Federal Register notice: FDA seeks comments on an information collection extension entitled Use of Public Human Genetic Variant Databases To Support C...