1 These guidelines published in the Federal Register on January 3, 2002 (67 FR 369) and were republished with corrections on February 22, 2002 (57 FR 8452).
2 All product reviews undergo extensive review through a hierarchical process (see Section V).
3 Good laboratory practices (GLPs) for nonclinical laboratory studies are discussed in 21 CFR 58.
4 Regulations at 21 CFR 312, guidances developed as part of the Agency's international harmonization efforts (for example, E6 and E8), and guidances developed by FDA that address clinical development of drugs to treat specific indications provide requirements and recommendations on good clinical practice (GCP). In addition 21 CFR parts 50 and 56 address issues related to informed consent and investigational review boards (IRBs), respectively.
5 FDA also administers an HHS Advisory Committee that has 18 panels.
6 This guidance is being updated and should be available soon.
7 Information on the FDA Ombudsman Program can be found at www.fda.gov/oc/ombudsman/homepage.htm.