Description
This draft guidance is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry “Assessment of Pressor Effects of Drugs” issued on May 31, 2018.
Scope & Applicability
Product Classes
1results from controlled trials of antihypertensive drugs; Reduction in Blood Pressure and Cardiovascular Events with Antihypertensive Drugs
Stakeholders
2Target audience for recommendations on assessment of overall survival
Primary source of experience data
Regulatory Context
Attributes
5applicable to new drugs with systemic bioavailability
Mean Change from Baseline in SBP / DBP
expected increases in ASCVD events for a chronic elevation in systolic blood pressure
Long-term drug administration duration
Brief drug administration duration
Identified Hazards
Hazards
1Safety concern regarding pressor effects
Related CFR Sections (1)
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
See Also (8)
- Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection (Status: Final)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability (Status: Draft)
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)