Simplifying Global Compliance
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Sept. 21, 2018
Vol. 17
No. 184
Headlines
Full Issue of Drug Industry Daily
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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to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday.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