An FDA panel got an earful on the review and regulation of drugs for amyotrophic lateral sclerosis Feb. 25 during a public hearing convened under the agency’s plan to involve patient networks in the regulatory process, particularly where it concerns lowering barriers to drug development for ALS.
Patients with amyotrophic lateral sclerosis are willing to tolerate a lot more risk than other stakeholders have assumed, advocates argued during a day-long public hearing Feb. 25 where they offered their advice on such topics as the design of clinical trials and access to experimental therapies to treat the aggressive and always-fatal neurodegenerative disease.
The meeting was part of the agency’s move to adopt a more patient-focused view toward drug development. A series of...
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
