On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
12/20/2022
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Prescription Drugs
On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more
3/2/2022
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Proposed Rules
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary -
On April 16, 2021, the Food and Drug Administration (“FDA”...more
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more