Remove Clinical Research Remove Production Remove Regulations
article thumbnail

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

article thumbnail

Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

Insiders

Sign Up for our Newsletter

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

article thumbnail

CDMO Selection: The Ultimate Checklist

Drug Patent Watch

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. Range of Services The range of services offered by a CDMO is another vital criterion.

article thumbnail

Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation

PPD

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

article thumbnail

Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Conversations in Drug Development Trends

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

article thumbnail

GxP Best Practices for Safer, Smarter, Faster Clinical Research

Advarra

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

article thumbnail

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.