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FDA Supporting Online Rare Disease Study Tool

[ Price : $8.95]

CDER director Janet Woodcock says a new natural history online tool developed with the National Organization for Rare Diseases can...

Too Soon to Say if Device Review Process is Better: Report

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A California Healthcare Institute report sees some improvement in CDRH review times and processes, but says there is still more th...

FDA OKs Cytori ATHENA Cardiovascular Trial

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FDA notifies Cytori Therapeutics that it can continue enrollment in its ATHENA cardiovascular trials thanks to data and protocol a...

Guidance on Tissue Surgical Procedure Exceptions

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Federal Register Notice: FDA releases a draft guidance for tissue establishments and professionals: Same Surgical Procedure Except...

FDA Clears Centric Medical Tarsa-Link System

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FDA clears a Centric Medical 510(k) for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in...

Dont Let 510(k) Guidance Become Back Door: MDMA

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MDMA says FDA should not use a draft guidance on 510(k) substantial equivalence decisions to reassess device classifications of pr...

Drug Companies Sharing Trial Data with Researchers

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Rutgers Biomedical and Health Sciences chancellor Brian Strom says an independent advisory committee he chairs encourages drug com...

FDA Approves Arbor NDA for Sotylize

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FDA approves an Arbor Pharmaceuticals NDA for its Sotylize (sotalol hydrochloride) oral solution, indicated for treating documente...

FDA Group Sets Base for Breast Cancer Master Protocol

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An FDA workshop lays the groundwork for a proposed master protocol that the agency is spearheading to advance an international gen...

Petition Seeks OTC Switch for Oral Contraceptives

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Attorney and former FDA director of medical device compliance Larry R. Pilot petitions the agency asking that it begin the adminis...