- BioPharm International-11-15-2003
- Volume 2003 Supplement
- Issue 4
Resolving Scientific and Technical Disputes
Resolving disputes with FDA over scientific and technical issues demands familiarity with existing practices and procedures, as well as understanding recent and ongoing changes to how FDA handles disputes.
In August 2003, FDA published a new draft guidance that proposes a formal process for resolving disputes of scientific and technical issues relating to current good manufacturing practice (cGMP) requirements (1). FDA is opening new opportunities for companies to interact with agency officials to resolve disputes more formally than in the past. FDA is now proposing to raise such disputes to the Office of Regulatory Affairs (ORA) and center levels — Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Veterinary Medicine — with options for reviews by a Dispute Resolution Panel for scientific and technical issues pertaining to pharmaceutical cGMP issues.
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