FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations...
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...
Drug and Device Corner 2026 February
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported...
Drug and Device Corner 2025 December
Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the...
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.