FDA Drug Approval Process Guide | PPT
Fresh from the biotech pipeline: fewer approvals, but biologics gain share | Nature Biotechnology
IJMS | Free Full-Text | Nanoparticles in Clinical Trials: Analysis of Clinical Trials, FDA Approvals and Use for COVID-19 Vaccines
List of globally marketed nanomedicines approved by the FDA and the EMA *. | Download Scientific Diagram
Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery
Low dose colchicine gets FDA approval for secondary prevention of heart disease
On Biostatistics and Clinical Trials: Guidelines for Blood Volumes in Clinical Trials (Especially in Pediatric Clinical Trials)
PDF) Data Integrity in Global Clinical Trials: Discussions from Joint US FDA and MHRA UK Good Clinical Practice Workshop
IJMS | Free Full-Text | Stem Cell Therapy: From Idea to Clinical Practice
Health Care Professionals - Clinical Summary
Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel - ScienceDirect
Machine learning-based quantitative prediction of drug exposure in drug-drug interactions using drug label information | npj Digital Medicine
A Consumer's Guide to Clinical Trials
Why 90% of clinical drug development fails and how to improve it? - ScienceDirect
Rusfertide Cuts Number of Needed Blood Draws to Treat PCV - NCI
FDA Approves CARVYKTI® and ABECMA for Early Treatment of Adult Patients with Relapsed or Refractory Multiple Myeloma | Moffitt
Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials - ScienceDirect
IJMS | Free Full-Text | Nanoparticles in Clinical Trials: Analysis of Clinical Trials, FDA Approvals and Use for COVID-19 Vaccines
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative | Therapeutic Innovation & Regulatory Science
The inner workings of site-less digital clinical trials – Part 2: The at-home blood collection kit - Scripps Research Digital Trials Center
Biomedicines | Free Full-Text | FDA Approvals of Biologics in 2022
Guidance for Industry
Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
FDA Gives Full Approval to First IgA Nephropathy Drug. Tarpeyo to Target Underlying Mechanism of Action in: Kidney News Volume 16 Issue 2 (2024)
Frontiers | A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations
FDA's Roadmap to Patient-Focused Outcome Measurement in Clinical Trials - National Health Council
Circulating blood volume and recommended maximum blood sample volume. | Download Table
