article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Drugs 59
article thumbnail

What Sponsors Need to Know About Medicare Coverage Analysis

Advarra

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

article thumbnail

Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. In this uncharted landscape, it is critical that clinical trial teams possess familiarity with past regulatory guidance as well as new technologies and methods for reducing regulatory risks.

article thumbnail

How Pharmacogenomics Can Benefit Your Clinical Trial

Conversations in Drug Development Trends

To learn more about these various genes and how they can affect your clinical trial participants, as well as to understand the full extent of the power of pharmacogenomics, check out our white paper. The post How Pharmacogenomics Can Benefit Your Clinical Trial appeared first on Worldwide Clinical Trials.

article thumbnail

Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs

PPD

Partnering with a contract research organization (CRO) that has deep experience in pediatric clinical trials enables drug developers to successfully implement these strategies, which also have the potential to enhance study startup time, ease the burden on pediatric patients and their caregivers, and ultimately improve retention rates.

article thumbnail

Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

The Pharma Data

Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center was created to provide sponsors of clinical trials pursuing in-house Covid-19 research with an AI-powered data analytics platform. Saama Technologies, Inc. ,