FDA Proposes Rule to Strengthen Accountability for Foreign Tobacco Product Manufacturers
FDA Proposes Rule to Strengthen Accountability for Foreign Tobacco Product Manufacturers FDA Announces Proposed Rule Affecting Foreign Tobacco Product Manufacturers The U.S. Food and Drug Administration has issued a proposed rule designed to strengthen oversight of...
FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products
FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products FDA Updates Enforcement Priorities for Unauthorized Tobacco Products FDA’s Center for Tobacco Products (CTP) has issued guidance titled “Enforcement Priorities for Certain...
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of...
FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced...
Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.