FDA’s biggest battle could be in the court of public opinion as employees claim the agency targeted and suppressed them based on their viewpoints and conducted intrusive searches and seizures. FDA says the surveillance began after a device industry attorney complained that a firm’s confidential information had been released.
Crisis management experts say FDA should tell the story behind its surveillance of employee emails to bolster its public image, even as the agency responds to questions from Congress about the operation.
The monitoring of employee online communications became public a year ago when current and former FDA employees filed suit against...
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.
