US FDA Adds Generic Insights On How To Demonstrate Nanomaterials Quality
Document sets final framework for assessing chemistry, manufacturing, controls and bioequivalence of a wide range of nanomaterials with new advice such as focusing analysis on the right therapeutic moiety.
You may also be interested in...
Calls are mounting for the EU to make the centralized procedure mandatory for follow-on versions of non‐biological complex drugs and for better regulatory alignment with the US and other countries.
US FDA draft guidance advises manufacturers to use 11 risk factors in evaluating the use of nanomaterials in drug products. It also urges manufacturers to pay close attention to excipients.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.