Direkt Links to important GMP Biologic Guidelines

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

Developing Medical Imaging Drug and Biological Products

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

Part 2: Clinical Indications

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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

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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.

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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

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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.

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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.

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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).

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Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS

The quality issues, including biological safety, affecting biological active substances5 produced by the expression of one or more transgenes stably located in the genomes of higher plants constitute the scope of this guideline.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

The objective of this guideline is to provide broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells to be used to prepare biotechnological/biological products defined in Section 1.3, Scope, and for the preparation and characterisation of cell banks to be used for production. The document, therefore, provides recommendations on the information in these areas that should be presented in marketing applications for these products.

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GMP Conferences by Topics

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