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Regulatory News | 09 December 2016 | By Zachary Brennan
Rep. Eric Swalwell (D-CA) on Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf seeking further assistance for start-up biotechnology companies in the Bay Area.
Swalwell said several companies have expressed their concerns on “the complexity and length of the regulatory process” that many do not have the resources to navigate. He also said the companies are seeking a local San Francisco Bay Area FDA office to provide face-to-face discussions on the regulations and science around drug development.
While recognizing that there are FDA offices in the region, Swalwell says they are primarily focused on regulating imports and “the lack of awareness of their existence shows more FDA outreach to the community is necessary.”
Letter
Tags: biotech, FDA, Francisco, in, San, start-ups