US OGD releases policy manuals

The US Office of Generic Drugs, a part of the Food and Drug Administration, has recently issued two Manuals of Policies and Procedures that became effective this month. The first concerns the review of Investigational New Drug applications for bioavailability or bioequivalence, and the second the procedures followed when bioequivalence study protocols are received for review.

MAPP 5210.5 - Review of Investigational New Drug Applications (Bio-INDs), describes the OGD policy and procedures for review of IND applications submitted for bioavailability or bioequivalence studies under 21CFR320.31. The term Bio-INDs distinguishes them from INDs for investigational new drugs submitted to the Office of New Drugs. Regulations require the Bio-IND, in specific instances, to ensure proposed products that are not new drugs are safe for use in human test subjects and do not expose them to undue risk.

MAPP 5210.6 - Procedures for Review of Bioequivalence Study Protocols describes the procedures to be followed when bioequivalence study protocols are received for review in the Division of Bioequivalence at the OGD. Since bioequivalence studies are frequently needed to support an ANDA, any sponsor planning to conduct a bioavailability or bioequivalence study should submit the proposed study protocol to OGD for prior review. OGD can then provide advice on appropriate study design, reference material, and proposed analytical and statistical methods to be used.