by Katrina Rogers | Jan 27, 2019 | Uncategorized
The final guidance for the Breakthrough Devices Program was issued by the FDA in December 2018. Under this program (part of the changes to the FD&C Act created by passage of the 21stCentury Cures Act), sponsors of devices or device-led combination products that...
by Katrina Rogers | Jan 24, 2019 | Uncategorized
Readers will remember my recommendation for Paul Gibbon’s book “The Science of Successful Organizational Change” from a previous post. Paul published his list of the best non-fiction books of 2018 in early January, and I believe the list deserves serious consideration...
by Katrina Rogers | Jan 22, 2019 | Uncategorized
The 21st Century Cures Act added a section to the FD&C Act to promote the qualification of drug development tools, including the qualification of biomarkers for use in drug development. Readers will recall my previous post on the FDA’s biomarker qualification...
by Katrina Rogers | Jan 20, 2019 | Uncategorized
In early January, CDER released its report on the 59 new drug therapies approved in calendar year 2018. Among the new drugs approved last year are treatments for rare diseases like phenylketonuria, the first in a new class of drugs to treat non-responding HIV-1...
by Katrina Rogers | Jan 15, 2019 | Uncategorized
Part 1 of 2The FDA has recognized that the current regulatory pathways for Software as a Medical Device (SaMD) do not let them assess the safety and effectiveness of new SaMD products at the pace of modern software development. This fact likely limits the availability...
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