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FDA issues a draft guidance to implement the voluntary reporting phase of its new quality metrics reporting program.[ Price : $8.95]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]
uno Therapeutics faces another setback on pushing its CAR-T cell product candidate through the development process after the compa...[ Price : $8.95]
FDA issues Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous admi...[ Price : $8.95]
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....