CDER touts its Safe Use Initiative as addressing OTC and Rx mis-use and reducing risks to consumers by partnering with industry stakeholders and health care professionals. CDER Professional Affairs and Stakeholder Engagement Director John Whyte says he wants to “build capacity” behind the program.
FDA’s Safe Use Initiative is considering proposals to fund research on kidney disease in black consumers linked to NSAIDs use, safe pediatric use of cough/cold medicines and impaired driving caused by OTC or Rx drug use.
John Whyte, the Center for Drug Evaluation and Research’s Professional Affairs and Stakeholder Engagement director, says those and other programs...
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.
