FDA, Import and Export Guidance Documents resource Agency Guidances OCEG Reviewed
The Food and Drug Adminstration's web site for import and export guidance information.
FDA, Guidance for Industry Process Validation: General Principles and Practices (2011) resource Agency Guidances OCEG Reviewed
Introduction: This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products.
FDA, Newly Added Guidance Documents - Drugs resource Agency Guidances OCEG Reviewed
Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.
FDA, Information for Industry (Drugs) Web Site resource OCEG Reviewed
The Food and Drug Administration's web site for topics of interest for business and industry regarding pharmaceuticals and over-the-counter drugs.
Life Sciences, Biotechnology and Pharma group
Pharmaceutical: Sales & Marketing Domain Supplement resource Standards and Guidelines OCEG Reviewed
This Supplement addresses the complex myriad of rules that must be addressed by pharmaceutical companies engaged in marketing and sales activities.
Prescription Drug Amendments of 1992, Public Law 102-353 resource National Laws OCEG Reviewed
Drugs for Human Use (21 C.F.R. Part 300 et seq.) resource National Regulations OCEG Reviewed
Prescription Drug Advertising (21 C.F.R. Part 202 et seq.) resource National Regulations OCEG Reviewed
Drugs; General (21 C.F.R. Part 200 et. seq.) resource National Regulations OCEG Reviewed
