FDA’s advisory committee members seem to be adopting the new post-marketing REMS authority with more enthusiasm than FDA’s own staff. Many of the advisory committee members – especially people who have served on the Drug Safety & Risk Management Advisory Committee – are jumping at the middle ground solution (between approval and rejection) offered by REMS. The Avandia re-review on July 13-14 demonstrated the strong appeal of REMS in a tough regulatory situation.
By Cole Werble
Duke cognition researcher Ruth Day and Colorado School of Public Health epidemiologist Elaine Morrato are part of an important new...
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Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.
As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
