The agency appeared unusually receptive to outside suggestions about a proposed questionnaire, dropping questions related to drug pricing and adding ones about exam room conversations.
FDA has altered a planned survey of how prescribers view direct-to-consumer (DTC) advertising by cutting several questions while attempting to glean more detailed information on the prescriber-patient relationship and prescribers’ demographics and feelings.
The agency deleted questions about “whether there should be more or less information about medical conditions in DTC advertising,” “in-office...
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.
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
