Investigators should be aware that studies that meet the definition of clinical trial may be subject to additional regulatory and/or policy requirements, such as posting of consent forms on federal ...

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration ...

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and compliant with global standards.

regional and country-specific regulatory and privacy requirements and clinical trial guidelines regarding participant data confidentiality. These are all critical consideration for sponsors ...

Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory ...

A doctor has reviewed your general health, and your health meets study requirements. We have answered ... and reported according to federal law and good clinical practice regulations. Clinical trials ...

evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets ...

-- TrialNet to conduct the Phase 2 randomized, placebo-controlled clinical study -- Nektar Announces Clinical Trial Agreement to Evaluate Rezpegaldesleukin in Patients with New Onset Type 1 ...

SAN FRANCISCO and NEW YORK, Feb. 24, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) and TrialNet, an international clinical trial network ... a novel agonistic T regulatory (Treg) cell ...