Direct Links to important GMP Biologic Guidelines

FDA Guidance for Industry: Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers

This guidance is intended to clarify Agency expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types.

FDA Guidance for Industry: Importation of Certain FDA-1 Approved Human Prescription Drugs, 2 Including Biological Products, under 3 Section 801(d)(1)(B) of the Federal 4 Food, Drug, and Cosmetic Act

This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 106 U.S.C. 381)

FDA Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining

FDA Guidance for Industry: Bridging for Drug-Device and Biologic-Device Combination Products

This guidance provides recommendations to industry and FDA staff on how to approach 19 bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-20 device and biologic-device single entity or copackaged combination products including the 21 following

FDA Guidance for Industry: Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products

This guidance describes FDA’s recommendations to investigational new drug sponsors for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two or more investigational drugs

FDA Guidance for Industry: Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers

This guidance provides recommendations to sponsors, applicants, and contract research organizations regarding internal standard (IS) response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications,abbreviated new drug applications, biologics license applications, and supplements

FDA Guidance for Industry: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)

FDA Guidance for Industry: Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA, or ANDA

This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA)

FDA Guidance for Industry: Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381)

FDA Guidance for Industry: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing

This guidance is intended to assist manufacturers in assuring the control of microbiological2 quality of their non-sterile drugs (NSDs).The recommendations herein apply to solid non18 sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topicallyapplied creams, lotions and swabs, and oral solutions and suspensions).

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