International Conference on Harmonisation; evaluation of stability data; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1E Evaluation of Stability Data." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products," which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717). It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product.     

International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled "Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV' (the Q1F guidance). The second is a revised guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.     

International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.     

International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3B(R) Impurities in New Drug Products.' The revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug products produced by chemically synthesized new drug substances not previously registered in a country, region, or member State. The revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance complements the ICH guidance entitled "Q3A(R) Impurities in New Drug Substances.'     

International Conference on Harmonisation; guidance on Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Notice

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes or provides recommendations concerning the selection of test procedures and the setting and justification of acceptance criteria for new chemical drug substances and new drug products produced from them. The guidance is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products.     

International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State.     

International Conference on Harmonisation; guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human Use; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use' (ICH S2(R1)). This guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH S2(R1) combines and replaces two ICH guidances, "S2A Specific Aspects for Regulatory Genotoxicity Tests for Pharmaceuticals' and "S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.' ICH S2(R1) provides guidance to drug sponsors on which tests should be performed to assess potential genotoxicity of pharmaceuticals. It also provides guidance on testing conditions, data interpretation, and followup strategies if a positive response is seen in in vitro assays. This guidance is intended to provide drug sponsors with recommendations to ensure that drugs are appropriately tested for potential to cause genetic damage and to ensure efficient development of new drugs.     

International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5D Quality of Biotechnological/Biological Products:Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and recommends information in these areas that should be presented in marketing applications.     

International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin, and outlines data that should be submitted in marketing applications.     

International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides guidance on general principles for the selection of test procedures and the setting and justification of acceptance criteria for biotechnological and biological products. The guidance is intended to assist in the establishment of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.     

International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#115) entitled "Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing"(VICH GL22). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the reproduction safety of veterinary drug residues in human food.     

International Conference on Harmonisation; draft guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products--FDA. Notice

The Food and Drug Administration (FDA) is publishing a draft guidance entitled "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products". The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides guidance on general principles for the selection of test procedures and the setting and justification of acceptance criteria for biotechnological and biological products. The draft guidance is intended to assist in the establishment of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.     

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (116) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing" (VICH GL23). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products(VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the genotoxicity of veterinary drug residues in human food in the European Union, Japan, and the United States     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."     

Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products." The draft guidance is intended to provide recommendations and offer alternative methods for sterility testing to confirm the integrity of container and closure systems for sterile biological products, human and veterinary drugs, and medical devices. The draft guidance applies only to the replacement of the sterility test with an appropriate container and closure integrity test in the stability protocol, and it is not offered as a replacement for sterility testing for product release.     

International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "S1B Testing for Carcinogenicity of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance outlines experimental approaches to evaluating the carcinogenic potential of pharmaceuticals to humans that may obviate the necessity for the routine conduct of two long-term rodent carcinogenicity studies     

International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the guidance is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. The guidance is intended to assist in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product.     

International Conference on Harmonisation; guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing); availability. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is intended to provide guidance on the duration of chronic toxicity testing in rodents and nonrodents as part of the safety evaluation of a drug product. FDA is also noting circumstances in which it may accept durations of chronic toxicity testing in nonrodents that differ from the duration generally recommended by ICH.     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.     

International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q8 Pharmaceutical Development." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.