Description
This guidance is intended to clarify the recommended approach for sponsors developing drugs to treat hypertension for patients who are on a background of multiple antihypertensive drugs.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
9possible treatment for hypertension
possible treatment for hypertension
possible treatment for hypertension
possible treatment for hypertension
commonly recommended drug class for initial therapy
commonly recommended drug class for initial therapy
commonly recommended drug class for initial therapy
commonly recommended drug class for initial therapy
results from controlled trials of antihypertensive drugs; Reduction in Blood Pressure and Cardiovascular Events with Antihypertensive Drugs
Stakeholders
1responsible for justifying omission of studies
Regulatory Context
Regulatory Activities
1paths to obtain approval of drugs
Document Types
1Document where unexpected behaviors might be listed as possible.
Attributes
1Product characteristic evaluated alongside name similarity.
Technical Details
Substances
1Medications taken during the study to be described in labeling
Testing Methods
1demonstrate superiority to placebo in reducing blood pressure
Clinical Concepts
6risk increased by elevated blood pressure
risk increased by elevated blood pressure
risk increased by elevated blood pressure
Elevated blood pressure is known to increase the risk of stroke; Prevention of Stroke by Antihypertensive Drug Treatment
hypertension not adequately controlled by three or more drugs
Indication for drug use
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