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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 ...[ Price : $8.95]
Federal Register Final Rule: FDA amends its nonprescription drug regulations to supplement the time and extent application (TEA) p...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled Nonprescription Sunscreen Drug Products Format and Content of Da...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance on Nonprescription Sunscreen Drug Products Safety and Effectiveness Data....[ Price : $8.95]
Eli Lilly says solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase 3 study in people with mil...[ Price : $8.95]
FDA issues a draft guidance to implement the voluntary reporting phase of its new quality metrics reporting program.[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled Contract Manufacturing Arrangements for Drugs: Quality Agreements...[ Price : $8.95]
FDA warns Indias Srikem Laboratories about CGMP violations and data integrity issues in its manufacturing of active pharmaceutical...