Pharmaceutical Industry News Roundup: September 2019

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on:

FDA Developing Guidance on Real-World Data Quality Issues, Officials SayRegulatory Focus

Two FDA officials recently wrote a perspective in the Clinical Journal of the American Society of Nephrology that the FDA is developing new guidance pertaining to real-world evidence. This new guidance will specifically target data quality issues when using real-world evidence.  

Zachary Brennan has the full story

5 Questions: Tina Hernandez-Boussard on Using ‘Real-World Data’ to Inform Clinical Care Stanford Medicine

Computational biologist Tina Hernandez-Boussard explains the advantages of using electronic health records as an information source. She believes that real-world data provides more representative information of the population.

Read the full blog article here

Protocol Problems Continue to Trip Up Investigators, FDA Data Show —CenterWatch

According to an FDA report on inspection findings in the fiscal year 2019, the biggest compliance problem for clinical trials is that they are unsuccessful at following investigational plans and protocols. The number of citations for this issue, however, have dropped since 2015.

Read the article by Leslie Ramsey

FDA In Brief: FDA Begins Reorganization Phase of Modernization Efforts to Increase Efficiency and Further Support New Drug DevelopmentU.S. Food & Drug Administration (FDA)

Last summer, the FDA announced its plan to modernize the FDA Center for Drug Evaluation and Research’s (CDER) New Drugs Regulatory Program (NDRP). This plan has been recently approved and will increase the number of review divisions within the CDER’s Office of New Drugs.

Get the latest FDA news here

Together, Data Scientists Set Standards to Solve Clinical Trial Data Challenges—PHUSE

Stephen Bamford, PHUSE founder and chairman of the board, explains why he founded the non-profit back in 2004. Today, PHUSE has nearly 10,000 global members and provides a collaborative forum in which stakeholders can address data science needs for health product development.

Read the latest news from PHUSE

Event Alert: Chicagoland Chapter: Patient Eligibility, Medical Histories, and Their Regulatory Implications—ACRP

Barbara Rusin, Senior Manager of Regulatory Compliance at MMS and former FDA investigator, will be presenting on patient medical histories at an ACRP Chicagoland Chapter event on October 2, 2019. More specifically, Rusin will be discussing regulatory implications of enrolling ineligible subjects and how to prevent this by obtaining and properly reviewing medical histories.  

Register now for this event 

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