April 3 (Reuters) - The U.S. Food and Drug Administration is suspending efforts to improve its bird flu testing of milk, cheese and pet food due to massive staff cuts at the agency, according to an ...
The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional ...
George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...
The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of frequently asked questions.
A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...
The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases ...
A multidisciplinary pre-review and single collaborative decision meeting replaces sequential NDA review, with FDA retaining discretion to extend timelines for ambiguity, incompleteness, or complexity.
Top FDA official shares the agency’s playbook for pushing manufacturers to remove synthetic dyes and reduce sugar and sodium – stressing the importance of collaboration with ‘co-regulators’ FDA could ...
Psychedelics have demonstrated significant progress, generating enthusiasm across the neuroscience industry and leading to successful independent companies. Rare neuromuscular and neurodevelopmental ...