Expert Insights

New FDA Guidance to Support Ultra-Rare Disease Drug Development

New FDA Guidance to Support Ultra-Rare Disease Drug Development

The FDA’s newest recommendations on clinical and CMC considerations for Investigational New Drug (IND) applications for the development of individualized ASO drug products for severely debilitating or life-threatening diseases join ASO guidance from earlier last year to further clarify the regulatory pathway for diseases identified in very few patients.

Looking back at 2021 – MMS Holdings year in review

Looking back at 2021 – MMS Holdings year in review

2021 brought more challenges and opportunities than ever before. From the starts and stops of opening workplaces, schools and economies to managing an overflowing email inbox, it can be challenging to keep up with all the information you need.

FDA Expedited Program Designations to Support Rare Disease Drug Development

FDA Expedited Program Designations to Support Rare Disease Drug Development

One in 10 Americans is affected by rare diseases—more than half of which are children—and approximately 95% of the more than 7,000 rare diseases have no available treatments. To advance the development of rare disease treatments, the Food and Drug Administration (FDA) Office of Orphan Products Development, OOPD.

Second Annual Global Champions of Change Competition Winner

Second Annual Global Champions of Change Competition Winner

MMS has just concluded its second annual Global Champions of Change Competition (G3C), where colleagues from all MMS regions submitted innovative ideas based on our tradition of providing high-quality, efficient services to our clients to help discover and market life-changing medicines to patients around the world.

How to use a Master Protocol to gain Efficiencies in a Clinical Trial

How to use a Master Protocol to gain Efficiencies in a Clinical Trial

The clinical development industry is an ever-changing field. It’s crucial to stay ahead of industry changes and ensure compliance with the needs of health authorities. Experienced medical writers understand the purpose of a trial and work closely with the study team to recognize efficiencies that may impact the study design or the long-term success of the clinical study.

Tips for Successful Medical Device Development and Approval

Tips for Successful Medical Device Development and Approval

For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device development and approval are regulated by the FDA, under the jurisdiction of the Center for Devices and Radiologic Health (CDRH).