|Title of guidance||Type and level of guidance||About the guidance||Source|
|Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS|
This document is unpublished. It is scheduled to be published on 14 Oct 2021.
|Draft, Level 1 guidance|
The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle
management of CM.
|S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals||Draft Level 1 guidance||This Addendum should used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines.|
This Addendum expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline.
This is an integrative approach that provides specific weight of evidence [WoE] criteria that inform whether or not a 2-year rat study adds value in completing a human carcinogenicity risk assessment.
The Addendum also adds a plasma exposure ratiobased approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply.
Application of this integrative approach would reduce the use of animals in accordance with the 3Rs (reduce/refine/replace) principles, and shift resources to focus onto generating more
scientific mechanism-based carcinogenicity assessments, while promoting safe and ethical
development of new small molecule pharmaceuticals.
|Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation||Final||This guidance discusses what types of information you, the applicant, should submit in your NDA or ANDA for a liposome drug product reviewed by CDER. The discussion addresses the following topics for liposome drug products: (A) chemistry, manufacturing, and controls (CMC); (B) human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and (C) labeling in NDAs and ANDAs. It finalizes the revised draft guidance for industry published in October 2015. The recommendations in this guidance focus on the unique technical aspects of liposome drug products. This guidance does not provide recommendations on clinical efficacy and safety studies; nonclinical pharmacology/toxicology studies; or drug-lipid complexes.||FDA|