The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The agency will only accept 15 cardiovascular breakthrough devices into the pilot program in the first year.
Existing guidance from 2005 needs to be updated because of significant changes that have occurred since then, including the introduction of the biological regulatory framework and the creation of emerging types of products, according to the agency.
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for late-stage pre-approval or post-approval studies when the safety of a drug is well-understood.
