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The FDA has issued a new guidance designed to help drugmakers identify compounds that could harm the immune system and provide direction on testing for such immunotoxicity.
The FDA is withdrawing two guidances on licensing blood products due to “a lack of industry interest” in pursuing either of the pilot programs, the agency said.
Topical oxygen chambers for extremities (TOCEs) would be reclassified as Class II devices under a draft "special control guidance" issued by the FDA April 6.
The Centers for Medicare & Medicaid Services (CMS) is dragging its feet in providing the necessary oversight to ensure laboratory genetic tests are valid, performed correctly and explained properly to patients, according to an advocacy group that says the tests are needed to realize the potential of personalized medicine.
The FDA has issued final guidance on how clinical trial sponsors should establish data monitoring committees (DMCs) to enhance protection of trial participants when safety concerns are unusually high (CTA, Jan. 12, Page 3).
The FDA wants manufacturers of orphan drugs and devices designated for humanitarian use to make regulatory submissions in an electronic format, according to a draft guidance.
The FDA has announced a 60-day public comment period regarding its renewed requirement that labeling content for prescription drug and biological products be submitted electronically, in a form the agency can process, review and archive.