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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...

Court Says Warning Letter Can be Final FDA Action

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Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybr...

Researchers Urge FDA Caution in Phasing Out Animal Testing

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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

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