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Each month, The FDA Group’s Insider Newsletter will deliver three pieces of regulatory and compliance news analyzed by former FDA staff and experienced life science consultants working in the FDA-regulated industries.
Each newsletter will contain a subscriber-only video of the expert contributor’s analysis with a transcript of the video and links to relevant articles and resources on the web. Subscribers will get actionable insights they won't find elsewhere.
There are a handful of free and paid regulatory intelligence services that report on new regulations, FDA guidances, enforcement actions, etc.
Many of these services do a decent job of putting need-to-know industry news in front of you, but few—if any—actually provide the expert analysis and perspectives that help you understand what you need to do in light of, say, new a guidance being issued. Even fewer go so far to break down warning letters and pick out the key lessons from them.
It’s up to you to digest the information, determine the impact on your organization, and plan accordingly. That takes time and attention that we suspect you could better invest elsewhere.
Watch our "pilot" edition and get a sense of what to expect each month. We've gathered a team of former FDA professionals and industry consultants as our expert contributors.
Subscribers will get exclusive access to videos like this every month—covering topics across the pharma, device, and biologics industries.
Our pilot features contributor Larry Stevens, RAC, a life science consultant who has held almost every field position within FDA during his 21-year career with the agency.
Regulatory affairs, quality assurance, and clinical operations teams need to stay on top of a fast-moving regulatory environment. Hunting for news and scouring databases steals valuable time that’s better spent elsewhere. The Insider Newsletter gathers important news so you don’t have to. Each month, we aggregate the latest relevant regulatory happenings and deliver expert analysis on key topics. Quickly scan regulatory updates from the FDA and stay for insights that help you take action on them.
It’s easy to get overwhelmed by the constant stream of regulatory information within the FDA-regulated industries. Keeping track of it all is hard enough. Understanding and responding to it thoughtfully is even harder. Our former FDA contributors analyze regulatory developments so you can focus on what it means for your organization and take efficient, effective action.