Description
The purpose of this guidance is to provide the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with type 2 diabetes mellitus. The recommendations in this guidance reflect discussions at the Endocrinologic and Metabolic Drugs Advisory Committee meeting held October 24–25, 2018, that considered FDA’s review of cardiovascular (CV) outcome trials (CVOTs).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2New drugs intended to improve glycemic control.
Products for which batch/lot information is particularly important
Stakeholders
2Independent committees providing oversight of safety findings.
Entities involved in drug development and discussion with FDA
Regulatory Context
Regulatory Activities
3Adult trials that should include adolescent participants.
Submission for drug approval
PMRs required by FDA; Studies or clinical trials conducted by the applicant after FDA approval
Document Types
1Collection of safety data needed to support drug approval
Attributes
2Specific severity of kidney disease required in the safety database.
Minimum exposure requirement in phase 3 clinical trials.
Technical Details
Testing Methods
2Rigorous method for assessing adverse CV events.
Trials used to evaluate cardiovascular risk in antidiabetic therapies
Clinical Concepts
10Important source of morbidity and mortality to be monitored.
Specific example of established CV disease.
correlated with female sex in VAD study
For studies in which the outcome or outcomes of interest (e.g., myocardial infarction or stroke) include fatal outcomes.
Cardiovascular disease, a common complication in the target population.
Condition requiring dietary restriction of sodium, potassium, or phosphorus
Specific cardiovascular safety outcomes monitored in trials
Safety concern evaluated in antidiabetic drug development
therapeutic intent of the medical devices
major comorbidities associated with excess adiposity; Common weight-related comorbidity
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2