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Trividia True Metrix Glucose Monitor Early Alert

[ Price : $8.95]

An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasiz...

Senate HELP Committee: 15 Ways to Reform FDA

[ Price : $8.95]

The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, ...

FDA DTC Crackdown Reshapes Industry Creative Approach

[ Price : $8.95]

Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping ...

FDA Shifts to Risk-Based Device Inspections under QMSR

[ Price : $8.95]

As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to cha...

PTC Yanks Translarna NDA After FDA Signals Data Shortfall

[ Price : $8.95]

PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, ...

Cotton Urges FDA Probe Into Chinese APIs for GLP-1 Drugs

[ Price : $8.95]

Sen. Tom Cotton (R-AR) urges FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients h...

FDA Rejects Commissioner's Voucher Drug

[ Price : $8.95]

FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic...

Zydus India Plant Cited After FDA Inspection

[ Price : $8.95]

FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic p...

FDA Should Move More Drugs OTC: Opinion

[ Price : $8.95]

Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certai...

Common Violations in Recent DTC Letters from FDA

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A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far...