The guidance is part of the broader FDA Drug Competition Action Plan that was introduced in June 2017 with the intent of increasing competition in the drug marketplace and facilitating entry into the market for lower-cost alternatives.
Read more: https://www.heartland.org/news-opinion/news/fda-issues-guidance-to-speed-approval-of-complex-transdermal-drugs

A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community.
Read more :https://www.forbes.com/sites/yiannismouratidis/2018/12/09/the-rise-of-use-of-medical-devices-force-fda-to-change-the-rules/#766e061c2101

The FDA has issued an update to its 2015 draft guidance on developing drugs to treat rare diseases. The new draft guidance, issued last month by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research within the FDA, contains several updates to the original document
Read more at: https://www.ajmc.com/newsroom/fda-revises-draft-guidance-on-developing-drugs-for-rare-diseases