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 payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product's approval. FDA's guidance documents ...
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 Commissioners and the Director of the Bureau of Consumer Protection (Jessica Rich) all spoke at the conference and relayed a message of the importance of consumer privacy and security. In that regard, the FTC speakers stressed the importance of:
- informing consumers of the ...
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 submitted for all applicable clinical trials, even those evaluating unapproved drugs and devices. Although we agree that this new requirement is likely to have significant ramifications for drug, biologic and device manufacturers, here are ...
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