MichBio knows full well that regulatory and compliance
policies have significant implications for bioscience companies and their research, development and
manufacturing activities, not to mention their business growth and bottom lines.
We aggressively advocate on regulatory-related matters by petitioning agency
officials, submitting formal comments, and pursuing legislative remedies both
in support of and in opposition to a variety of policies and regulations pursued
by regulatory agencies.
The U.S. Food & Drug Administration (FDA) provides the most oversight to the bio-industry by far. MichBio continues to strongly support the full funding for FDA while expecting clear, transparent, and predictable review processes. Recent years have seen the agency:
encumbered by sequestration of its user fees
negotiate existing device and pharmaceutical industry user fee agreements and new ones governing generics and biosimilars
propose major overhaul of its 510(k) pre-market review process
pilot a Center for Medicare & Medicaid Services parallel review process
implement a Unique Device Identifier regulatory program
enhance food quality oversight and inspection
release numerous guidance documents in areas like mobile health and software, social media, combination drug products and more
MichBio has been engaged on each of the issues noted above and continues to track FDA-related matters to ensure that our members are informed and represented on regulatory policy.