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.

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.

Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.

Lilly representative suggests having more informal communication with FDA and consistent feedback across divisions. The firm had a positive experience participating in CID pilot with master protocol for chronic pain therapies.

Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.

Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.