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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...[ Price : $8.95]
CDRH director Jeffrey Shuren and two colleagues say the Center has been using patient-focused data to help in the review of some m...[ Price : $8.95]
Public Citizen faults FDA for issuing a final guidance on changing informed consent requirements without an opportunity for public...[ Price : $8.95]
Federal Register notice: FDA announces an 11/16 public hearing on a potential approach for device sponsors who seek to obtain mark...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Classification of Products as Drugs and Devices & Additiona...[ Price : $8.95]
An EY Pulse of the Industry 2017 report urges medtech companies to act now to address cybersecurity issues rather than waiting for...[ Price : $8.95]
FDA denies a US WorldMeds petition asking for specific conditions on any applicant proposing a drug-device combination with apomor...[ Price : $8.95]
The Justice Department advises the 3rd Circuit Court of Appeals that a federal district court failed to recognize that some state ...