An Approval 30 Years In The Making: FDA Re-Approves Morning Sickness Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
Canadian-based Duchesnay’s Diclegis has the same active ingredients as Bendectin, which was withdrawn in 1983 in the wake of litigation; FDA says epidemiological studies have shown the combination of drug ingredients does not pose an increased risk of harm to the fetus.
You may also be interested in...
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.
Off-Label Communication: Industry Opposes Exclusion Of Phase II Data From US FDA’s Guidance
Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.