Drugindustrydaily

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Sept. 21, 2018

Vol. 17
No. 184

Headlines

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

Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Read More

Expert Committee Recommends Patient-Focused Dissolution Standards

An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Read More

Allergan Loses Bid to Dismiss Restasis Antitrust Suit

Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to have the multi-district litigation dismissed. Read More