MMS Holdings Expert Insights Blog

Are you working on annual submissions that utilize the current FDA Annual Report format? Are you concerned about the mandatory adoption of the FDA DSUR (development safety update report)? Below are five reasons to embrace the change and place the DSUR at the center of...

The Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...

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...

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...

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...

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...

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...

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...