FDA Announces Availability of Multiple Draft Guidances - Drug Information Update

August 26, 2022

Today, FDA announced the availability of the following draft guidances for industry, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):

FDA Announces Availability of Multiple Draft Guidances:

Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development (Read the Federal Register)

These draft guidances harmonize international scientific approaches for analytical procedure development and include validation of a wider range of analytical techniques. Additionally, these guidances are intended to facilitate regulatory evaluations and potential flexibility in post-approval change management of analytical procedures where scientifically justified. When fully realized these two guidelines will speed regulatory evaluations and enhance the availability of quality drugs to the public.

M12 Drug Interaction Studies

The draft guidance is intended to decrease the risk of adverse events from interactions associated with taking more than one drug. Drug-drug interactions can sometimes lead to hospital admissions or reduced treatment efficacy. This draft guidance harmonizes international recommendations for in-vitro and clinical evaluation of drug-drug interactions for a more consistent approach in design, conduct, and interpretation of enzyme and transporter-mediated interaction during the development of an investigational drug. This draft guidance also provides general recommendations on how to evaluate the pharmacokinetic drug interaction potential mediated via enzyme and transporter for investigational drugs.

E11A Pediatric Extrapolation 

This draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The draft guidance provides alignment of terminology, information on various approaches that can be utilized to support the use of pediatric extrapolation, and a discussion of the types of study designs, statistical analyses, and modeling and simulation approaches that can be utilized. This guidance also aligns approaches to pediatric extrapolation globally so that there is greater likelihood of agreement in pediatric development programs across international regulatory authorities.

ICH’s goal is to foster development of uniform, scientifically driven, international standards to improve the efficiency of new drug development and promote public health by, among other things, preventing duplication of clinical trials and minimizing the use of animal testing. Within ICH, FDA collaborates with other international regulatory authorities and industry associations to harmonize global standards for the development of safe, effective, and high-quality medicines. These efforts are achieved through a transparent, science- and consensus-based process for guideline development that includes opportunities for public comment and a commitment of regulators to implement its guidelines and standards

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.


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