Japan Issues Draft Guidance On Microdosing
This article was originally published in PharmAsia News
Japan's Ministry of Health, Labor and Welfare has issued a draft guidance on microdosing in an effort to encourage companies to make quicker development decisions related to early stage compounds. The draft guidance defines a microdose as a single dose of less than 1/100th of a dose of a test substance calculated to yield a pharmacologic effect, with a maximum dose of no more than100µgs. Microdosing has been implemented in both the U.S. and European Union; the draft guidance is the first such measure in Japan. The draft guidance is expected to be implemented in Japan as early as March; MHLW is accepting comments on the document until Feb. 8. (Click here for more.
You may also be interested in...
The US FDA issued only one device-related close-out letter in October.
Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.
Several experts spoke with Scrip about their take on how the biopharmaceutical industry's efforts to respond to COVID-19 might help industry's image problem.