Agency is considering creating a pool of pre-screened patient representatives that would make it easier to place them in FDA-sponsored formal meetings and advisory committees.
Increasing patient involvement in FDA application reviews also may lead to the agency quickening its screening for conflicts of interest.
Reforms requiring an increase in the patient voice at FDA as well as loosening conflict of interest regulations to include...
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The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.
The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.
MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.
The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.
Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.
FDA’s former CBER director is joining industry as senior VP of molecule discovery and head, infectious disease at Eli Lilly.
CMS Administrator Oz punted on a GLP-1 question in an interview, suggesting it was because his agency will be acting soon.
