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Sept. 24, 2018

Vol. 15 No. 185

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Allergan Loses Bid to Dismiss Restasis Antitrust Suit

“The inferences plaintiffs draw — namely, that Allergan's efforts bore fruit in causing delay — are logical and amply support the plausibility requirement,” the judge said. Read More

Sponsors Who Don’t Report Trial Data Could Be Hit With Fines, FDA Says

The agency will prioritize cases where sponsors have failed to submit trial registration or results for higher-risk trials. Read More

FDA Issues Guidances on Prescription Drug Identifier Requirements

A separate final guidance outlines exemptions from certain requirements. Read More

FDA Adds Immediate-Release Opioids to REMS to Expand Training, Labeling

FDA Commissioner Scott Gottlieb said the action introduces “a more stringent set of requirements.” Read More

Expert Committee Recommends Patient-Focused Dissolution Standards

“I believe it’s something that’s going to have wide support,” said temporary voting member Paul J. Smith, director of the University of Maryland’s statistics program. Read More