The U.S. Food and Drug Administration (FDA) makes available guidance for industry titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” The document “defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.”

The U.S. Food and Drug Administration (FDA) issues guidance for industry and staff titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” It makes recommendations “to consider and document in FDA medical device premarket submissions to provide effective cybersecurity management and reduce the risk that device functionality is intentionally or unintentionally compromised.”

The U.S. Patent and Trademark Office launches a new free service with the State Intellectual Property Office of China to “allow the two offices to electronically exchange patent application priority documents directly.” The service is intended to “help streamline the patent application process and reduce costs for businesses which are increasingly pursuing patent rights globally.”