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Quality Metrics Data Guidance Out

[ Price : $8.95]

FDA issues a draft guidance to implement the voluntary reporting phase of its new quality metrics reporting program.

Guide on CMO Quality Agreements

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Juno Setback on CAR-T Cell Product After Another Trial Mishap

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uno Therapeutics faces another setback on pushing its CAR-T cell product candidate through the development process after the compa...

FDA Complete Response on Green Cross Immunoglobulin

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FDA issues Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous admi...

Drug Trial Design Depends on Knowledge: Woodcock

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CDER director Janet Woodcock says drug developers must use the entire clinical development program and not just a trial to answer ...

Final Rule on Time and Extent Sunscreen Reviews

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Federal Register Final Rule: FDA amends its nonprescription drug regulations to supplement the time and extent application (TEA) p...

Guide on Sunscreen Data Submissions

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Federal Register Notice: FDA makes available a guidance entitled Nonprescription Sunscreen Drug Products Format and Content of Da...

Guide on Sunscreen Safety/Effectiveness Data

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Federal Register Notice: FDA makes available a guidance on Nonprescription Sunscreen Drug Products Safety and Effectiveness Data....

Lilly Scraps Alzheimers Drug After Study Miss

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Eli Lilly says solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase 3 study in people with mil...

CGMP Violations at Indias Srikem Laboratories

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FDA warns Indias Srikem Laboratories about CGMP violations and data integrity issues in its manufacturing of active pharmaceutical...