Friedman said FDA is considering release of stability guidance
This article was originally published in The Gold Sheet
CDER's Friedman reported at the June 23 meeting that any type of stability guideline issued by FDA will be "small scale," designed to complement the ICH guideline on stability testing. Friedman noted that FDA withdrew its stability guidance when the ICH guidance was issued in 1997. Other guidances due out soon, reported Friedman, include a new guidance on process validation and a guidance on parametric releas
You may also be interested in...
With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between the EU and UK in medtech regulation.
Days after a senior Chinese government official offered free COVID-19 vaccines to the Philippines government, the country’s medicines regulator said the donated jabs would need an emergency approval before they can be used on the public.
Interview: recently appointed CEO Richard Francis will apply his background in big pharma and biotech to building the UK start-up Purespring Therapeutics with a focus on using gene therapy technology to target renal diseases.