Category: Regulatory/FDA

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WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment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CHC Press Release: Comment on Social Media Draft Guidance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

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

OPDP Issues First Untitled Letter for Branded Facebook Page

Cuts in Speaker Payments Should Be Placed in Proper Context