Regulatory Sciences
Preparing for eCTD 4.0: What FDA Submitters Need to Know
Why Early Planning Matters for Regulatory Operations While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory...
Regulatory Sciences
Influencers in Pharma: A Growing Compliance Frontier
As digital marketing evolves, prescription drug promotion is expanding into spaces traditionally dominated by consumer brands. Pharmaceutical companies are increasingly collaborating with...
Regulatory Sciences
FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications
On Tuesday, September 9, 2025, the Department of Health and Human Services (HHS) and FDA both issued press releases and a fact sheet launching a crackdown on deceptive drug advertising. In the FDA's...
Regulatory Sciences
FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025
On September 25, 2025, FDA posted an additional 11 Untitled Letters from the cohort of letters issued on September 9, 2025, bringing the total number of compliance letters directed toward...
Regulatory Sciences
Decoding FDA’s Recent Advertising Enforcement Actions
The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug...
Regulatory Sciences
Omnichannel Marketing in Pharma: A Strategy Guide for Regulatory Compliance
As emerging marketing technologies rapidly evolve and reach maturity, marketers can now unlock sophisticated new tools to more efficiently and effectively reach consumers. As always, marketers remain...