by Prakash Achaary | Jan 24, 2022 | Blog
FDA’s Recent Benefit Risk Assessment Guidance Explained: What It Means for Sponsors by Natalie Pizzimenti, Medical Writer; Ben Kasper, Director, Regulatory Affairs; Amanda Beaster, Senior Manager, Regulatory Strategy In September 2021, the Food and Drug Administration...
by Olivia Grant | Jan 10, 2022 | Blog
New FDA Guidance to Support Ultra-Rare Disease Drug Development by Dr. Amanda Beaster, Senior Manager of Regulatory Strategy Antisense oligonucleotide (ASO) drug products target a specific sense mRNA to modulate gene expression in living cells and have been...
by Prakash Achaary | Dec 22, 2021 | Blog
Looking back at 2021 – 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...
by Prakash Achaary | Dec 1, 2021 | Blog
FDA Expedited Program Designations to Support Rare Disease Drug Development By: Christine Clarke PhD, Senior Medical Writer 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...
by Prakash Achaary | Nov 3, 2021 | Blog
MMS Announces Second Annual Global Champions of Change Competition Winner: Colleague Participation in Organization Innovation By Jim Balcom, Director of Partnerships and IT Governance MMS has just concluded its second annual Global Champions of Change...
by Prakash Achaary | Oct 8, 2021 | Blog
How to use a Master Protocol to gain Efficiencies in a Clinical Trial By: Tasnim Hoda, Manager of Regulatory and Medical Writing and Aaron Burr, Senior Medical Writer The clinical development industry is an ever-changing field. It’s crucial to stay ahead of...
