Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with
Device Manufacturers
FTC Focus on Privacy
At the International Association of Privacy Professionals (“IAPP”) Global Privacy Summit in Washington, D.C. on March 5th and March 6th, the Federal Trade Commission (“FTC”) was clear in its message that privacy was a top priority for the agency. The FTC had a strong presence at the conference. Three of the five…
FTC Focus on Privacy
By Patricia Wagner on
Posted in Privacy and Security Law
At the International Association of Privacy Professionals (“IAPP”) Global Privacy Summit in Washington, D.C. on March 5th and March 6th, the Federal Trade Commission (“FTC”) was clear in its message that privacy was a top priority for the agency. The FTC had a strong presence at the conference. Three of the five…
Five Issues to Consider While Reviewing the Clinical Trial Registration Proposed Rule
By Daniel Gottlieb on
Posted in FDA
Earlier this week the Department of Health and Human Services (“HHS”) published its long awaited notice of proposed rulemaking regarding the registration of clinical trials. The most significant change that would result from implementation of the proposed rule, and the one getting the most press, is the new requirement that results data be …