Product Details

FDA warning letters drop as audit preparation increases

Warning letters issued to investigators by the FDA’s Center for Drug Evaluation and Research (CDER) have dropped 13% (annualized) during the past five years as the industry has strengthened efforts to ensure sites comply with regulatory requirements that safeguard data integrity and human subject protection in clinical trials.

MSLs play growing role in patient care and clinical research

Still an underutilized resource, medical science liaisons can serve as a bridge between science, economics. Originally hired by sponsors to perform outreach with payers and providers while their drugs were awaiting FDA approval, MSLs have seen their role evolve dramatically over time into more of a global pharmacological resource who can present data in a fair and clear way for the improvement and benefit of patients and the overall public health sector.

Also in this issue:

• Coming to grips with the Sunshine Act
• Choosing a functional service provider
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline