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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...

Federal Register

Proposal to Clarify Medical Product Intended Use

Federal Register proposed rule: FDA proposes to amend its medical product intended use regulations to describe the types of evidence relevant to deter...

Human Drugs

FDA Denies Without Comment Taiho Lonsurf Petition

FDA denies without comment on potential future action a Taiho petition seeking restrictions on generic versions of its Lonsurf tablets.