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FDA Releases Modified List of Device Standards

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Federal Register Notice: FDA releases Modifications to the List of Recognized Standards, Recognition List Number: 040.

FDA Renews Mammography Advisory Committee

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Federal Register Notice: FDA renews the charter of the National Mammography Quality Assurance Advisory Committee for two years.

Guidance on IVDs to Detect HPV

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Federal Register Notice: FDA releases a draft guidance on establishing the performance characteristics of in vitro diagnostic devi...

Workshop on Neurodiagnostics/Brain Stimulation Devices

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Federal Register Notice: FDA plans a public workshop 11/19-20: Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices...

Advisory Board to Center for Toxicological Research to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 11/3-4.

FDA Clears NOWDiagnostics Fast Pregnancy Test

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FDA clears a NOWDiagnostics 510(k) for the AdexusDx hCG point-of-care test, which uses a single drop of capillary or whole blood t...

Pfizer Seeks Clarification on Biosimilar Protein Content Similarity

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Pfizer says FDA needs to provide more information to biosimilar sponsors on how they are expected to demonstrate that the protein ...

Guidance on Exempting Certain Devices from Premarket Notification

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Federal Register Notice: FDA releases a guidance: Intent to Exempt Certain Unclassified, Class 2, and Class 1 Reserved Medical Dev...

Guidance on Rare Disease Drug Development

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FDA posts a draft guidance on Rare Diseases: Common Issues in Drug Development that is intended to assist sponsors developing prod...

FDA Approves Baxter Cefazolin in Galaxy Container

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FDA approves Baxter Internationals cefazolin injection in its Galaxy container (2 g/100 mL), a flexible container that uses the co...