Devices

Medical Device Signal Guidance

CDRH has issued a draft guidance, Public Notification of Emerging Postmarket Medical Device Signals, describing FDA’s policy for notifying the public about medical device “emerging signals.” For purposes of the guidance, an emerging signal is defined as new information about a medical device used in clinical practice (1) that

Drugs

FTC Policy Against Deceptively Formatted Ads

The Federal Trade Commission (FTC) has issued an enforcement policy statement about advertising and promotional messages integrated into and presented as non-commercial content, often referred to as “native advertising”. The statement summarizes the principles underlying the commission’s enforcement actions, advisory opinions, and other guidance over many decades addressing