We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Christmas came early for carotid stent manufacturers this year in the form of a Centers for Medicare & Medicaid Services (CMS) draft coverage decision proposing expanded Medicare coverage for carotid stents.
Drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms — including crystalline and amorphous forms, as well as solvate and hydrate forms — according to a draft guidance released by the FDA.
Makers of implantable radio-frequency transponder systems can soon begin marketing their devices without being subject to 510(k) premarket notification requirements, according to an FDA guidance document.
With an aim toward ensuring consistency and understanding between the FDA and clinical trial sponsors, the agency has issued a guidance document addressing general clinical data presentation formats for research studies involving orthopedic implant devices.
The FDA has released a draft compliance guidance to help firms understand new OTC product labeling requirements as well as prepare new labeling within prescribed implementation compliance dates.
Eli Lilly has launched an online, publicly accessible registry on which it will post the results from all Phase I through Phase IV clinical trials for its marketed drug products.
The American Health Information Management Association (AHIMA) has asked HHS Secretary Tommy Thompson to use any undesignated and/or unspent discretionary funds in the department’s budget to support HHS’ new Office of the National Coordinator for Health Information Technology (ONCHIT).
The FDA will not take action against firms that submit, via annual report, postapproval manufacturing changes made to comply with an official compendium, the agency announced in a Nov. 21 guidance document.
The FDA has released a draft guidance document detailing how the agency’s Center for Drug Evaluation and Research views positive findings in genetic toxicology assays during drug development.
To foster as much drug price competition as possible, the Centers for Medicare & Medicaid Services (CMS) has established 34 regions through which to administer the Medicare prescription drug benefit — a move that follows last week’s draft guidance ensuring drug plan sponsors have flexibility in designing their formularies.