Five King & Spalding attorneys review the nine advertising and promotion enforcement letters FDA issued in 2022.
FDA clears a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years a...
An FDA clarifying notice says the agency will continue to make orphan drug exclusivity decisions based on a drugs specific approved uses/indications a...
FDA plans to discuss 1/26 a new strategy to annually select Covid-19 strains in June for immunizations beginning no later than September each year.
FDA issues its long-awaited final guidance entitled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance fo...
Johnson & Johnsons DePuy Synthes medical device unit agrees to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kic...
A citizen petition by Soft Lights Foundation urges FDA to issue regulations under 21 CFR Part 1040.41 to regulate electromagnetic radiation in the vis...
A citizen petition asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that r...
