FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity

Feb 26, 2026 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary

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

Feb 24, 2026 | Drug and Device Corner, Drugs, Medical Devices

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

Dec 22, 2025 | Drug and Device Corner, Drugs, Medical Devices

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)

Dec 2, 2025 | Drugs, Medical Devices, Seminar, Tobacco

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.

21 CFR Part 11 (Electronic Records & Signatures) Compliance for Computer Systems Regulated by FDA

Dec 2, 2025 | Drugs, Medical Devices, Seminar, Tobacco

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated, or “GxP” computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in 1997 and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic, or system of record.

Drug and Device Corner 2025 November

Nov 24, 2025 | Drug and Device Corner, Drugs, Medical Devices

For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments. The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User...