Wednesday, July 1, 2015
FDA draft guidance on individual patient expanded access application form
Gender still plays a role in biotech, with venture financing closely following male CEOs and all male boards, found Liftstream, a London-based company providing executive recruitment services to the biotechnology sector. Liftstream has published a new gender diversity report, Investing in Biotechnology Management, a study of venture financing and hiring trends in European and U.S. biotechnology companies and the gender representation on the boards and at the executive level. The research analyses 110 investment deals in private biotechnology companies as well as 308 biotech executive appointments.
The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.
Pharmaceutical Research and Manufacturers of America (PhRMA) has formally introduced new Expanded Access principles to assist companies in evaluating whether to voluntarily grant patients access to an investigational treatment. Originally introduced to its members last December for review and discussion, PhRMA’s newly implemented Expanded Access principles were recently adopted with commitments from each member.
Schulman Associates IRB, a central IRB in customer service and technology, recently began build-out of its new office space on Laboratory Drive in Research Triangle Park, Durham, N.C. The location will house review board and administrative staff, including IT, operations and customer service professionals.
The NIH Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. FDA representatives inspected the PDS and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.
FDA draft guidance on acceptance of medical device clinical data from studies conducted outside the U.S.