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FDA Tightens Antibody Test Requirements

[ Price : $8.95]

Faced with the mounting concerns about test reliability after 200 Covid-19 serology (antibody) tests went on the market without n...

Tolmar Pharma Drug Approved for Early Puberty

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FDA approves a Tolmar Pharmaceuticals NDA for Fensolvi (leuprolide acetate) for injectable suspension for treating pediatric patie...

FDA Accepts KemPharm NDA for ADHD Drug

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FDA accepts for review a KemPharm NDA for its investigational product candidate KP415 (serdexmethylphenidate) for treating attenti...

FDAs Covid-19 Battle a Legal Test for Industry: Author

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FDA law book author Roseann Termini joins other voices warning that FDAs Covid-19 battle will be a test of regulated industrys leg...

FDA Postpones Domestic/Foreign Inspections Indefinitely

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FDA says it postponing domestic and foreign inspections indefinitely during the Covid-19 emergency.

Lawmakers Bill on American Drug Independence

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Rep. Anna G. Eshoo (D-CA) and Rep. Susan W. Brooks (R-IN) introduce legislation entitled Prescription for American Drug Independen...

Updated Guide on Covid-19 Convalescent Plasma

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FDA issues an updated guidance on Investigational Covid-19 Convalescent Plasma.

Guide on Nicotine Delivery System Enforcement

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Priorities for Electronic Nicotine Delivery Sys...

Info Collection on Animal Drugs for Minor Species

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Federal Register notice: FDA sends to OMB an information collection extension for Index of Legally Marketed Unapproved New Animal ...

Guide on Posterior Cervical Screw Systems

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FDA posts a final guidance entitled Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.