US FDA's Abram Makes The Case For 180-Day Exclusivity Reform
Proposed trigger changes will discourage low-quality applications, not disincentivize patent challenges, deputy commissioner suggests at generic association's annual meeting.
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US FDA's demand for commercial-scale data for memantine extended-release during ANDA review did not amount to change in 'requirements for approval,' judge rules, upholding agency determination that Amneal forfeited marketing exclusivity for failure to obtained tentative approval within 30 months.
Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies
Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.
Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.