FDA PET radiopharmaceuticals policy
This article was originally published in The Gray Sheet
Executive Summary
The agency is discussing its proposed policy on the regulation of positron emission tomography radiopharmaceuticals at a public hearing March 5. The draft policy, entitled "Regulatory Approach to PET Radiopharmaceuticals," is expected to be available in several weeks....
You may also be interested in...
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on the major topics facing the biopharma sector in the region.
Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification
Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.