FDA Plans Five Biosimilar, Three Social Media Draft Guidances In 2014
Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
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Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
The draft guidance outlines substantial reporting requirements for websites that firms control and for content on third-party sites – as well as saying when FDA intends to use enforcement discretion.
Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.