Newsletter | September 7, 2023

09.07.23 -- New FDA Postmarketing Data On Underrepresented Populations Guidelines


ISR Reports has been filling the need for higher-quality market research in the pharmaceutical industry for over 15 years. Utilizing a rigorous primary research methodology, ISR offers off-the-shelf reports, as well as unparalleled custom research services. Their website also hosts several free resources covering topics such as CDMO and CRO selection, clinical development, drug manufacturing, eClinical technology, decentralized trials, the cell and gene market, and more. Visit ISR's homepage here.


What Do The New FDA Postmarketing Data On Underrepresented Populations Draft Guidelines Mean For Pharmaceutical Companies?

New FDA draft guidelines create a path forward for companies that need time after approval to thoroughly examine a drug’s efficacy and safety for diverse, underrepresented patient populations.

New And Emerging CMS Policies: Medicaid’s Clinical Trial Policy

Explore the primary factors institutions should consider to navigate impending CMS changes and what to anticipate for the future of enrollment for Medicaid beneficiaries.

Cell And Gene Therapy Global Regulatory Report

Get a global overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage, and approved products, covering cells, genetically modified cells, and gene therapies.

Evaluating Abuse Potential Of CNS-Active Drugs For EU And U.S.

Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

End-To-End Safety Solutions For Every Engagement

As one of the world’s largest and most experienced safety and PV organizations, discover how IQVIA is bringing extensive domain expertise and deep regulatory intelligence to the life sciences industry.

Expert Regulatory Filings To See Your Regulatory Strategy Through

Veristat’s regulatory publishing team offers extensive expertise across the full scope of regulatory requirements, including your applications, amendments, supplements, and reports.


Webinar: Slow The Burn — How To Mitigate Financial Risk Before Selecting An Outsourcing Vendor

When you’re in the heart of a clinical trial, facing unexpected budget changes and unplanned change orders can put your entire program at risk. Join this webinar to learn the best practices for safeguarding your trial's budget. Click here to learn more.


Cautious Optimism For Biotechs And Their Outsourcing Partners

Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted, but also stand to gain the most, after the economic downturn and during the subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.

Top Tips For Taming CRO Turnover

How do you handle CRO employee turnover? Cathy Gooch, senior VP of people operations and culture at Biorasi, discusses the importance of culture, communication, and connection.

Multitherapeutic Limitations: How To Choose The Right Resource

Chief medical officers looking for outsourcing services are often fed lines from large CROs on how they can provide individuals with multitherapeutic backgrounds. Learn to determine which lines are true.

Evaluating A CRO For Rare Disease Studies: A Checklist For Success

When launching an RFP, refer to this checklist to ensure comprehensive coverage of all aspects when evaluating potential research partners for a rare disease study.

Sponsor Perspectives On Outsourced Clinical Trial Logistics

Demystify the mystical by uncovering the mystery in clinical trial logistics. Get answers on how sponsors select a provider, what activities they outsource most, and where the questions are heading.


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