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Hurricane Damage to Puerto Rico Likely to Cause Shortages: FDA

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FDA worries about medical product shortages as the damage from a hurricane that devastated Puerto Rico is assessed as worse than f...

CDRH Seeing Patient Preference Benefits: Shuren

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CDRH director Jeffrey Shuren and two colleagues say the Center has been using patient-focused data to help in the review of some m...

No Justification for Lack of Input on Informed Consent: Advocates

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Public Citizen faults FDA for issuing a final guidance on changing informed consent requirements without an opportunity for public...

Public Hearing on New Device Use with Approved Drugs

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Federal Register notice: FDA announces an 11/16 public hearing on a potential approach for device sponsors who seek to obtain mark...

Guidance on Product Classifications

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Federal Register notice: FDA makes available a final guidance entitled Classification of Products as Drugs and Devices & Additiona...

Companies Should Address Cybersecurity Now: Consultants

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An EY Pulse of the Industry 2017 report urges medtech companies to act now to address cybersecurity issues rather than waiting for...

FDA Denies Drug-Device Parkinsons Petition

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FDA denies a US WorldMeds petition asking for specific conditions on any applicant proposing a drug-device combination with apomor...

DoJ Questions Court Ruling on Device Preemption

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The Justice Department advises the 3rd Circuit Court of Appeals that a federal district court failed to recognize that some state ...

FDA Announces Pre-Certification Software Pilot Participants

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FDA commissioner Scott Gottlieb says the agencys new Pre-Cert for Software pilot program is moving forward with the selection of n...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Shandong Vianor Biotech and Vicare International.