Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Title:
Guidance for Industry: Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
Content:
This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).