Congressman Phil Gingrey (R-GA)’s Generating Antibiotic Incentives Now Act (H.R. 2182
GAIN Is Great: Now Who Gets the Benefits?
Congress is set on enacting a package of antibiotic development incentives—but needs to sort out how best to define the targets.
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CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
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Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
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PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.
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Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
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Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
• By
PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.