Regulatory Affairs

Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs

Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More

Eisai Suing FDA Over Shortened NCE Exclusivity

New Jersey-based Eisai is suing the FDA over the exclusivity clock assigned to two of its products, claiming the government arbitrarily shortened its five-year exclusivity period from generics competition. Read More

FDA Considers Changes to 180-Day Exclusivity Decisions

The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More