Direct Links to important GMP Biologic Guidelines

Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

This guidance document provides recommendations for the submission of a biologics license application (BLA) (21 CFR Part 601) for placental/umbilical cord blood products that are: manipulated minimally; and intended for hematopoietic reconstitution in patients with hematological malignancies; and intended to be used in recipients unrelated to the donor.

more

FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs

This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).

more

FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments

Developing Medical Imaging Drug and Biological Products

more

FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications

Part 2: Clinical Indications

more

FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies

Design, Analysis, and Interpretation of Clinical Studies

more

FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications

This document provides recommendations for sponsors of investigational new drugs (INDs) and applicants submitting new drug applications (NDAs) or biologics license applications (BLAs) on the use of exposure-response information in the development of drugs, including therapeutic biologics.

more

FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information

This document provides guidance to industry on formal meetings between sponsors of investigational new drug applications (INDs) and the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) on chemistry, manufacturing, and controls (CMC) information. This guidance applies to INDs for human drugs and biologics

more

FDA Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications

This document provides guidance to applicants on submitting abbreviated reports and synopses in lieu of full reports for certain clinical studies, both in marketing applications for new drug and biological products and in supplements to approved applications.

more

FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products

This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness.

more

FDA Guidance for Indutry M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

This guidance primarily addresses the organization of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived and biological products).

more

GMP Conferences by Topics