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Germitecs Chronos Gets De Novo Marketing Pass

[ Price : $8.95]

FDA awards de novo marketing clearance to Germitecs Chronos automated disinfection device for reducing the risk of cross-contamina...

Guide on X-Ray Device Regulations

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Clarification of Radiation Control Regulations for Manufact...

FDA Discusses Optimizing Advisory Committees

[ Price : $8.95]

FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advi...

FDA Approves Motiva Breast Implants

[ Price : $8.95]

FDA approves Establishment Labs Holdings Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for breast augmen...

Dupixent Approved for COPD Add On

[ Price : $8.95]

FDA approves Sanofi and Regenerons Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled...

FDA OKs New Schizophrenia Drug

[ Price : $8.95]

FDA approves Bristol-Myers Squibbs Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults.

Advisory Committee Consumer Reps Sought

[ Price : $8.95]

Federal Register notice: FDA seeks consumer organizations interested in participating in the selection process for voting or nonvo...

OMB Clears 4 Informaton Collections

[ Price : $8.95]

Federal Register notice: FDA announces that four information collections have been approved by OMB.

Appeals Court Gives FDA a Win on Stem Cells

[ Price : $8.95]

The U.S. 9th Circuit Court of Appeals reverses an earlier California lower court decision that ruled a stem cell treatment firm is...

FDA-passed Parkinsons Drug Part of Falsified Research Probe

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An investigation by the journal Science questions the data behind a Parkinsons drug under development by Prothena and based on fal...