ICH E6(R3), a significant development on the regulatory horizon, is a revision to the International Council for Harmonization's guidelines for Good Clinical Practice and is slated for release in August 2023. As the healthcare industry continues to evolve, it's...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Preparing for a GxP Audit Interview: Tips and Considerations for Auditors and Auditees
When it comes to undergoing a GxP audit interview within the regulated GxP industry, it's important to be well-prepared by understanding the objectives and scope. This is particularly true for clinical research audits, which involve assessing compliance with both...
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...
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...