Compliance takeaways from FDA’s final ‘intended use’ rule
By 
Jaclyn Jaeger2021-09-07T19:08:00
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
THIS IS MEMBERS-ONLY CONTENT
You are not logged in and do not have access to members-only content.
If you are already a registered user or a member, SIGN IN now.
Related articles
-
News BriefFDA bans Red No. 3 dye after decades of concerns over possible health risks
The U.S. Food and Drug Administration announced Wednesday it has revoked authorization for color additive Red No. 3 from food, beverages, and drugs. Health concerns over dye have existed since it was banned from cosmetics in 1990 after it was found that large doses led to the development of cancer ...
-
ArticleTop Ethics and Compliance Failures of 2025
The 2025 year has been so rich with compliance stinkers, and rife with poor judgment, compliance missteps, outright malfeasance and greed, greed, greed, that it was almost impossible to choose just six epic compliance failures from this year’s massive poop pile.
-
WebcastCPE Webcast: Hot Topics in Risk and Compliance: AI, Analytics, and Emerging Audit Technologies
Join experts from KPMG, Cisco, and Workiva as they explore how audit, accounting, and finance professionals can leverage a technology mix of data analytics, gen AI, and other tools to ramp up efficiency and strengthen control effectiveness.
More from Regulatory Policy
-
PremiumEU financial firms must prepare now for new rules on critical third-party arrangements
European banks and financial institutions must prepare now for stringent new rules on third-party suppliers.
-
ArticleTrump tirade against DEI turns to proxy advisors and shareholder proposals
President Donald Trump has directed the Securities and Exchange Commission (SEC) to review—and remove—any SEC rules or guidance that allow proxy advisors to influence business practices related to diversity, equity and inclusion (DEI) and environmental, social and governance (ESG) policies.
-
ArticleTrump takes aim at state AI laws, promises federal action on AI legislation
President Donald Trump has issued an executive order aimed at dismantling the artificial intelligence (AI) laws of California, Colorado and three other states with comprehensive laws.