Tag Archives: FDA

SCOTUS Opinion: Court Clarifies “Clear Evidence” Standard For Failure-To-Warn Claims

Merck manufactured the drug Fosamax to combat osteoporosis in postmenopausal women. Merck’s scientists theorized that use of Fosamax might cause atypical femoral fractures, but the drug label approved by the Food and Drug Administration in 1995 did not include a warning for those fractures. After 1995, evidence of such fractures started to develop. In 2008, Merck applied to the FDA... Read More >

Patent Holders May Not Use Federal Law To Issue Injunctions Against Applicants For Biosimilar Products

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated process for the FDA to approve drugs that are biosimilar to already licensed biological products. The Act, in part, requires an applicant for a biosimilar product to provide its application and manufacturing information to the patent holder within 20 days of the date the FDA notifies the applicant... Read More >