Senator Cassidy Criticizes FDA for Failing to Clarify Device Patent Requirements for Orange Book Listings

"The FDA's continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements," said Senator Bill Cassidy.

"Lack of Clarity from FDA Created Vacuum Leading to FTC Enforcement Campaign," emphasizing the impact of the FDA's inaction on industry operations and regulatory clarity.

"For companies manufacturing drug delivery products, questions exist regarding whether device patents should be included in Orange Book listings for approved drugs."

"The FDA denied requests for advisory opinions, leading to an absence that allowed the FTC to step into the vacuum, causing confusion in the industry."

Read at IPWatchdog.com | Patents & Intellectual Property Law