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Yates Memo Accountability Eased

[ Price : $8.95]

Attorney Anne Walsh outlines Justice Department changes to the Yates memo on individual accountability in criminal and civil cases...

FTC Supports FDA Deterring Petition Abuse

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The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic ...

6 Observations in Gadea Biopharma FDA-483

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FDA releases an FDA-483 with six observations from an inspection at Spains Gadea Biopharma.

Info Collection Extension for Drug Supply Chain Guide

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Federal Register notice: FDA has submitted to OMB an information collection extension entitled Guidance for Industry: Drug Supply ...

InSightecs Exablate Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for InSightecs medical device E...

Info Collection Extension on Device e-Registration & Listing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic Submission of Medical Devic...

FDA Approves Olympus Device for Emphysema

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FDA approves Olympus Spiration Valve System for treating severe emphysema, a progressive form of chronic obstructive pulmonary dis...

Improvements to FDA Adaptive Design Guidance Praised

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PHRMA praises FDA for its new draft guidance on adaptive designs for clinical trials of drugs and biologics.

FDA Clears Subtle Medical AI Technology for Images

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FDA clears a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence-powered technology that the company says allows h...

FDA Clears Bausch & Lomb Astigmatism Contact Lens

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FDA clears a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens.