In December 2023, back when the ink was still drying on the amendments to Federal Rule of Evidence 702, the Southern District of New York excluded all five general causation experts proffered by plaintiffs in the In re...more
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more
On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).
Under...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
6/22/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Revocation ,
Secretary of HHS
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more