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e7-studies-in-support-of-special-populations;-geriatrics;-questions-and-answers Drug Test
  • February 3, 2025

E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers

International Council on Harmonisation – Efficacy
gingivitis:-development-and-evaluation-of-drugs-for-treatment-or-prevention Drug Test
  • February 3, 2025

Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention

Clinical / Medical
real-world-data:-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological-products Drug Test
  • February 3, 2025

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

Guidance for Industry
fda-acceptance-of-foreign-clinical-studies-not-conducted-under-an-ind:-frequently-asked-questions Drug Test
  • February 3, 2025

FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions

Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked Questions
real-world-data:-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory-decision-making-for-drug-and-biological-products Drug Test
  • February 3, 2025

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Real World Data/Real World Evidence
exposure-response-relationships-—-study-design,-data-analysis,-and-regulatory-applications Drug Test
  • February 3, 2025

Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications

Clinical Pharmacology
exploratory-ind-studies Drug Test
  • February 3, 2025

Exploratory IND Studies

Guidance for Industry, Investigators, and Reviewers – Exploratory IND Studies, Investigational New Drug Applications
exception-from-informed-consent-requirements-for-emergency-research Drug Test
  • February 3, 2025

Exception from Informed Consent Requirements for Emergency Research

Informed Consent Exception for Emergency Research – Guidance
e6(r2)-good-clinical-practice:-integrated-addendum-to-ich-e6(r1) Drug Test
  • February 3, 2025

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

International Council on Harmonisation – Efficacy
data-standards-for-drug-and-biological-product-submissions-containing-real-world-data Drug Test
  • January 31, 2025

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Data Standards for Drug and Biological Product Submissions Containing Real-World Data