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FDA Wants Comments on REMS Vendor Changes

[ Price : $8.95]

FDA asks for answers to several questions about factors that should be considered in requests from sponsors of drugs subject to RE...

ICH Good Clinical Practice Guide Comments

[ Price : $8.95]

The International Council for Harmonization releases for public comment a draft document entitled ICH Harmonized Guideline Good C...

FDA Seeks Contractors for Drug Performance Automation

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FDA asks for proposals to develop artificial intelligence systems to assist it with drug product imaging and analysis.

Digital Medicine Society Praises FDA Help

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The Digital Medicine Society praises FDA for its work in addressing using digital health technologies in drug and biological produ...

FDA Warns India Pharmacy Over Unapproved Drugs

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FDA warns Gujarat, India-based Champaklal Maganlal Homeo Pharmacy Private Limited and two New Castle, DE-based companies that they...

SD Biosensor Recalls Contaminated Covid Tests

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SD Biosensor recalls its Pilot Covid-19 At-Home Test due to microbial contamination.

Call Out Lawyer Client-Seeking Ads: Petition

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A University of Florida law professor calls on FDA to define personal injury attorney client-seeking ads that cross a line and may...

FDA Denies Petition for PPI Pneumonia Warning

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FDA denies an Alliance for Natural Health citizen petition urging the agency to require all makers of proton pump inhibitors to ex...

Contract Testing Lab Gets Warning Letter

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FDA sends contract testing laboratory Sure-Biochem Laboratories a Warning Letter after a 10/2022 inspection cited significant GMP ...