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DTC Ad Drug Pricing Amendment Passes Senate

The Senate passes a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) requiring pharmaceutical companies to list p...

Medical Devices

Dthera Sciences Breakthrough Status for Alzheimers Device

FDA grants Dthera Sciences a breakthrough device designation, for its Alzheimers treatment, DTHR-ALZ.

Human Drugs

Trial Inclusion, Exclusion Workshop Report

FDA releases a report summarizing its 4/16 public workshop on clinical trial inclusion and exclusion.

Federal Register

Comments Sought on Sunscreen Info Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Sun Protection Factor Labeling and Testing Requirements fo...

Federal Register

Draft Guide on Osteoarthritis Structural Endpoints

Federal Register notice: FDA makes available a draft guidance entitled Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and...

Federal Register

Members Sought for Device Advisory Panels

Federal Register notice: FDA requests nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device ...

Federal Register

Danicrine Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale for reasons of safety ...

Medical Devices

Class 1 Recall of bioMerieux Vitek 2 Test Cards

FDA classifies as Class 1 a bioMerieux recall of its Vitek 2 Gram Positive Antimicrobial Susceptibility Testing Cards due to false results for some st...

Human Drugs

Biocodex Seizure Drug Approved by FDA

FDA approves a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two years of age and olde...

Medical Devices

FDA Approves Roches Test for Iressa

FDA approves Roches cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZenecas Iressa (gefitinib) in ...