An Institute of Medicine workshop on companion diagnostics suggests that regulatory standards are evolving at FDA to encourage companion diagnostic development. But almost everything else is still a challenge.
“This is not an FDA or regulatory issue,” Third Rock Ventures’ Felix Frueh declared during his opening presentation to an Institute of Medicine workshop on companion diagnostics February 28.
“I do not believe regulatory hurdles exist. I believe the hurdles are on the business and reimbursement side.”
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
