A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0
Similar Posts
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsFDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Review Goals SummaryFDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the boxed warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs.Joinn Laboratories Co. Ltd. – 09/20/2013
Joinn Laboratories Co. Ltd. – 09/20/2013. Country: China. Record Type: 483MedWatch: The FDA Safety Information and Adverse Event Reporting Program
MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.Generic Competition and Drug Prices
FDA report demonstrating greater competition among generic drug makers can lead to lower generic drug prices.