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CRL for ARS Pharmaceuticals Neffy

[ Price : $8.95]

FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.

Kimera Labs Illegally Marketing Exosomes: FDA

[ Price : $8.95]

FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP ...

CDRH International Harmonization Plan

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FDA publishes a draft CDRH strategic plan for medical device international harmonization.

More 510(k) Changes Likely: Attorneys

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Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to...

Guide on Drug Substantial Evidence

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...

FDA Converts ASCA from Pilot to Permanent

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FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.

Houston Man Sentenced in Counterfeit Drugs Case

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A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit d...

Guide on Drug Substantial Evidence

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...

E-signature, E-records Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Electronic Records; Electronic Signatur...

Info Collection on Fellowship Program

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Application for Participation in FDA F...