Zdrowie i gospodarka · 12.01.2006
Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP." The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.