The US agency is re-evaluating its criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs. A 2014 guidance on cord blood products could serve a template, industry suggests.

The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21^st Century Cures Act and strongly suggests that most of these products will be regulated via class II.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.