FDA Administrative Enforcement Manual

Parker draws on her extensive experience to give pharmaceutical companies and researchers the basics on critical FDA administrative enforcement issues, and includes regulations, lawsuit case studies, and reference materials to clarify regulations and practices. She explains the authority and responsibility of the FDA and how it administers recalls, corrections, withdrawals, civil actions, and criminal actions (including debarment, disqualification and application compliance and integrity). She cites case studies, including those regarding FDA 483 forms, seizures and injunctions. She includes a very close reading of the FD&C Act of 1938, a synopsis of drug law history, descriptions of the roles and responsibilities of clinical investigators, a transcript of the FDA Administrative Procedures Act (FAPA), and a glossary.