Navigating Orphan Drug Designations: Strategy and Compliance
In the niche but rapidly expanding field of orphan drugs—medications specifically developed to treat rare diseases affecting fewer than 200,000 individuals in the U.S.—understanding the regulatory landscape is crucial for […]
Plain Language Communication in Healthcare Part 1 Webinar
Plain Language Communication in Healthcare – Part 1: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences Healthcare companies such as medical device manufacturers and pharma/biotech […]
Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs
In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs. Recently, the […]
