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FDA grants Novavax fast track status for its RSV F-Protein nanoparticle vaccine candidate.[ Price : $8.95]
Six stakeholder groups praise FDAs risk-based approach to regulating drug compounding.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on risk and benefit perception scale development to the ...[ Price : $8.95]
CDRH extends until 9/24/16 the compliance date for unique identification system labeling requirements for medical devices meeting ...[ Price : $8.95]
FDA proposes drug advertising research to give it a pool of measurement tools to evaluate consumer perceptions of risk and benefit...[ Price : $8.95]
FDA denies a petition to permit a drug company to submit an ANDA demonstrating bioequivalence to BioMarins Kuvan sold in Israel ra...[ Price : $8.95]
Mallinckrodt asks a Maryland federal court to stop FDA from reclassifying its generic form of Concerta from AB to BX.[ Price : $8.95]
The Drug and Device Law Blog says a New Jersey court decision allowing a Reglan failure-to-warn claim to go forward will likely no...