US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.
You may also be interested in...
Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.
In the first of a three-part series on the evolution of mRNA manufacturing, this article looks back to before the pandemic, when dogged mRNA researchers and entrepreneurs labored in obscurity pursuing the dream of revolutionizing health care by commandeering the body’s own protein building process to generate quicker, cheaper vaccines and therapeutics. Then the mRNA COVID-19 vaccines stunned the world.
The US FDA has issued guidance on how it will continue to use remote technology to assess agency regulated facilities, a practice that became popular during COVID-19 travel restrictions.