FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
The U.S. Food and Drug Administration (FDA) provides detailed guidance on the nonclinical studies required to support Investigational New Drug (IND) applications. The document,…
Read more →Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide
The U.S. Food and Drug Administration (FDA) continues to modernize regulatory processes by encouraging electronic submissions for Investigational New Drug (IND) applications. The FDA’s…
Read more →CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
The U.S. Food and Drug Administration (FDA) plays a critical role in overseeing the safety and efficacy of investigational drugs before they enter clinical…
Read more →Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
The U.S. Food and Drug Administration (FDA) continues to evolve its regulatory framework to incorporate advancements in digital health technologies (DHTs). The FDA’s guidance…
Read more →Bioresearch Monitoring Technical Conformance Guide
The U.S. Food and Drug Administration (FDA) plays a pivotal role in establishing regulatory standards for drug development and approval. The FDA’s guidance document,…
Read more →Control of Nitrosamine Impurities in Human Drugs
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring that the pharmaceutical supply chain remains resilient and that drug shortages…
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