Pharmaceutical Industry News Roundup: June 2019

by Staff writer

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 ‘open for business’ in considering real-world evidence, Sharpless says BioPharmaDive

The US Food & Drug Administration (FDA) is currently considering real-world evidence to clear expanded uses of new cancer drugs. While the FDA is open to the possibility of using real-world evidence in clinical trials, the agency warns industry leaders in becoming too reliant on alternate data sources.

Kim Dixon has the full story on BioPharmaDive.

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesicsU.S. Food & Drug Administration (FDA)

The FDA recently drafted new guidance to help assess the benefits and risks of opioids entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.” This new guidance seeks to thoroughly describe the assessment framework that the agency uses to evaluate opioid analgesic drug applications and more.

Read the full statement via the FDA newsroom.

Two additional countries to benefit from EU-US mutual recognition agreement for inspections European Medicines Agency (EMA)

The FDA recently confirmed the capability of Luxembourg and the Netherlands (both EU member states) to carry out good manufacturing practice inspections at a comparable level to that of the US. The agreements carried out by the EU and US are based on robust evidence and similar regulatory frameworks.

The entire article can be accessed via the EMA newsroom

New Time-Saving Application Launched to Automatically Perform Quality Control and Style Checks for Medical Writers MMS Holdings

MMS Holdings announced the launch of Automatiqc™ (pronounced: automatic). Automatiqc is a new cloud-based application that automatically performs quality control (QC) and style checks for medical writing, pharmacovigilance, clinical trial transparency, and other types of documents in the pharmaceutical, biotechnology, and medical device industries – cutting QC time by up to 33 percent.

Learn more about Automatiqc here

Health Canada Issues Guidance on Off-Label Uses of Drugs in Trials – CenterWatch

Health Canada released new guidance regarding the study of off-label benefits of drugs in clinical trials. This guidance was issued as public officials worried that previous regulations delayed the progress of live-saving research.

Read the story via CenterWatch

Partner News: TrialAssure launches TrialResults.com for Clinical Trial Sponsors to Publicly Post Plain Language SummariesTrialAssure

TrialAssure announced the launch of TrialResults.com, a new portal for sponsors to publicly share plain language summaries with clinical trial participants. This portal allows trial participants to access lay summaries while reducing the burden for sponsors who do not have their own public portal.

Learn more about TrialResults.com

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