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Research and Development Clinical Trials Healthcare

McDermott Will & Emery

Key Takeaways | Clinical Research Technology (ClinTech)

McDermott Will & Emery on

During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Manatt, Phelps & Phillips, LLP

The Real Challenges That Stop Hospitals From Integrating Clinical Trials Into Clinical Care

Editor’s Note: In the autumn issue of the Clinical Research as a Care Option (CRAACO) newsletter, an interview with Manatt Health’s Donna O’Brien gives pharma readers insight into how hospitals view trials, some of the...more

McDermott Will & Emery

Five Key Considerations for Study Pre-Screening and Recruitment Initiatives in the Digital Age

McDermott Will & Emery on

Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more

Health Care Compliance Association (HCCA)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

Manatt, Phelps & Phillips, LLP

New FDA Draft Guidance Encourages Industry Focus on Improving Clinical Trial Diversity

Last week, in the midst of the Biden Administration’s coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity. In a...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

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