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FDA Shifts to Risk-Based Device Inspections under QMSR

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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

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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

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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

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

Zydus India Plant Cited After FDA Inspection

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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

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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...

Medline Class 1 Recall on Malfunctioning Beds

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

Antimicrobial Drug Duration of Use Guidance

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FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions o...

Authorize Generic GLP-1s: Public Citizen

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Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nord...