Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient
This article was originally published in The Pink Sheet Daily
In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.
You may also be interested in...
Commissioner Hamburg describes a Catch-22, warning that pressure to finalize guidances faster without more resources could result in fewer discretionary guidances, disappointing stakeholders.
FDA has started implementing changes called for in a draft guidance on labeling of drugs granted accelerated approval throughout the last three-quarters of 2014, without waiting for the final guidance or even the comment period to close.
Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.