MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
A Comprehensive Guide to Preparing for a Successful Good Laboratory Practice (GLP) Inspection
Good Laboratory Practice (GLP) compliance is an important aspect of research and development, as it creates trust and transparency between stakeholders in the process. When inspections occur, it is important to have all the necessary preparations in order, so the...
New 2023 FDA Guidance on REMS: What’s New?
The Risk Evaluation Mitigation Strategy (REMS) is a drug safety and risk management program established in 2007 by the U.S. Food and Drug Administration (FDA). Under the program, FDA might require manufacturers to implement specific safety measures for certain...
5 Expert Tips to Avoid FDA Form 483s in Your Analytical Laboratory
FDA Form 483s, more commonly referred to as 483s in the pharmaceutical industry, is a nonconformance issued by the Food and Drug Administration at the close of an inspection. Feared by everyone in the industry, this type of observation can elicit panic in the...
A Reflection on My Medical Writing Career: The Art of Mentoring
Gary Pekoe, Principal Medical Writer at MMS, has over 35 years of experience working professionally in the pharmaceutical industry. We’ve asked him to write an article on his mentoring experience over his career. Looking back over my career in the pharmaceutical...
MMS Scientific Advisory Board’s New Members Expand CRO’s Therapeutic Expertise
CANTON, Mich. (March 21, 2023) – MMS Holdings, an award-winning, data-focused CRO, announced today the addition of Dr. Philip Breitfeld and Dr. Bernhardt Zeiher to its board of scientific advisors. Both industry leaders in innovative clinical trial delivery solutions,...
New FDA Policies and Procedures for Products Submitted Under Accelerated Pathways : Understanding CDER MAPP 5015.13
The FDA recently developed a new Manual of Policies and Procedures (MAPP) to address the challenges of Chemistry, Manufacturing and Control (CMC) readiness for products with accelerated clinical development programs. This MAPP became effective on December 7, 2022 and...
10 Things to Consider When Discussing and Planning a Decentralized Clinical Trial (DCT)
Full or Hybrid decentralized clinical trials (DCTs) are facilitating new treatments through the advancement of clinical development in many therapeutic areas and will likely be incorporated into more trials every year. To make this transition as successful as possible...
SENDing Successful Nonclinical Submissions through Validation, Review, and Beyond
The CDISC Standard for the Exchange of Nonclinical Data (SEND) requirements for US Investigation New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) requirements, designed to improve the ease of nonclinical data review...
Orphan Drug Designations in the EU: Recent Rare Disease Treatment Updates
aTyr Pharma, Inc. was recently granted orphan drug designation by the European Commission (EC) for Efzofitimod for the treatment of sarcoidosis. Sarcoidosis is characterized by the accumulation of immune cells that form granuloma, which typically begins in the lungs,...