MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

Key Takeaways from FDA GCP Inspection Trends in 2021

Key Takeaways from FDA GCP Inspection Trends in 2021

The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. The FDA’s Office of Regulatory Affairs (ORA) is the lead office for inspections and enforcement. ORA...

read more
How to Get an FDA Orphan Drug Designation

How to Get an FDA Orphan Drug Designation

The Orphan Drug Act provides incentives to sponsors to promote the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than 200,000 individuals in the United States, and for which the sponsor is not...

read more