PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 1, 2011
May 15, 2020
a4320966-98dd-464c-8b5e-d455c45c3f0e
Related Documents
Shelf Life of Medical Devices
Guidance DocumentApril 1, 1991Center for Devices and Radiological Health
CPG Sec 490100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
Guidance DocumentMarch 12, 2004Office of Regulatory Affairs
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs
Guidance DocumentAugust 9, 2000Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.