Category: Regulatory/FDA

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

FTC Calls for Data Broker Legislation To Protect Consumers

OPDP Enforcement Letters Address Omission of Risk Information

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

FTC Cites Privacy Concerns Related to Mobile Health Apps

FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

CHC Press Release: Comment on Social Media Draft Guidance

Some States Impose Reporting Requirements That Add to Sunshine Burden