Month: July 2025
Lessons Learned: Analysis of Complete Response Letters from FDA
Byron Fitzgerald, Founder of ProGen Search analyzes complete response letters from the FDA. This report takes a deep dive into 202 complete response letters and where therapeutic deficiencies fall and what to consider as you plan, whether due to clinical efficacy concerns, manufacturing challenges, safety data gaps, or regulatory misalignment. Click here for the 202…
Sword Bio Appoints Nina Sahay, as Head of Quality Assurance
Sword Bio (“Sword”), a contract research organization that supports biotech and pharmaceutical companies with their bioanalytical needs for pre-clinical and clinical trials, announces the appointment of Nina Sahay as Associate Director of Quality Assurance. Nina Sahay, RQAP-GLP joins Sword Bio as the Associate Director of Quality Assurance and brings with her over 20 years of…