FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

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

[ Price : $8.95]

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

Medline Class 1 Recall on Malfunctioning Beds

[ Price : $8.95]

Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warning that continued use without ...

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...

Researchers Urge FDA Caution in Phasing Out Animal Testing

[ Price : $8.95]

A new academic paper urges FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that mov...

FDA Faces High Hurdle to Expand DTC Ad Disclosures: WLF

[ Price : $8.95]

A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramati...