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Regulatory & Compliance
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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.

KEY ISSUES

Legislative 

21st Century Cures Initiative

FDA Funding

Food & Drug Administration Safety & Innovation Act (FDASIA)

FDA Safety over Sequestration (SOS) legislation

Track and Trace Legislation: Drug Quality and Security Act of 2013


Regulatory Policy

510(k) Rules Modifications

FDA Guidances - Draft and Final

OTC Monograph Process

Unique Device Identification (UDI)

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
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