FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria
The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.
Exploring the Evolving Landscape of Ophthalmology Clinical Development
Few fields in clinical research are as dynamic and promising as ophthalmology. With the global population ageing and eye diseases becoming more prevalent, there is a growing demand for innovative treatments and therapies. This blog explores the emerging trends and updates that are shaping the ophthalmology clinical development landscape.

Accelerating Patient Recruitment in Ranibizumab Study for Retinopathy of Prematurity in Preterm Infants
Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies
The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.
FDA and Clinical Trials: Ensuring Safety and Efficacy
FDA and Clinical Trials: Clinical trials stand as the cornerstone of pharmaceutical and biotech advancements, enabling new treatments and therapies to reach patients worldwide. At the helm of this transformative…