FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.
The US Food & Drug Administration is formally proposing to require essentially all “lab-developed” tests to comply with the medical device regulations governing in vitro diagnostic tests – including pre-approval requirements – before the end of the decade.
The proposed rule released on 29 September continues a decades-long effort to bring LDTs into regulatory harmony with IVDs....
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
