An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandated approval deadline.
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach that could reduce use of horseshoe crab blood in endotoxin testing.
An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandated approval deadline.
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach that could reduce use of horseshoe crab blood in endotoxin testing.
Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extensive stage small cell lung cancer.
