Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

OMB 0910-0563

OMB 0910-0563

Disputes about scientific and technical issues relating to current good manufacturing practice requirements (CGMP) may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements, or during FDA's assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures for raising such disputes to FDA's Office of Regulatory Affairs (ORA) and center levels and for requesting review by a dispute resolution (DR) Panel.

The latest form for Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice expires 2021-05-31 and can be found here.

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