CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.
FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as they apply to hemp-derived cannabidiol products in medical research.
President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in his administration’s “Most Favored Nation” drug pricing initiative, according to several media reports.
