On the heels of FTC’s “Operation Full Disclosure,” which resulted in 60 warning letters, commission officials advise all advertisers to pay close attention to their disclosures and ensure they are clear and conspicuous. The initiative included review of 1,000 national television and print ads, and the agency says it will continue to monitor the advertising landscape for inadequate disclosure use.
Federal Trade Commission officials advise all advertisers to review their ad disclosures, even those who did not receive warning letters as part of the agency’s recent “Operation Full Disclosure” initiative.
Announced Sept. 23, the initiative resulted in warnings to 60 advertisers for failure to make adequate disclosures, following review of...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
