Regulatory Insights

  1. Clinical Trial Transparency: The Technology Imperative

    This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.

  2. Rapid Change, Real Promise: The Future Of Rare Oncology Research

    Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

  3. EudraVigilance Survival Guide

    What it is, why it is important, and what sponsors need to think about as it gets closer.

  4. Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar

    In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.

  5. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  6. Regulatory Requirements For Medical Devices In China

    Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.

  7. SCOPE 2019 Highlights – Beyond The Pilot, Moving Towards Implementation

    Recently, nearly 2000 participants attended the 10th Annual Scope Meeting. Read the expert perspectives, insights gained from lessons learned and forward-looking predictions across 10 parallel tracks focused on functional areas and emerging disciplines within clinical development.

  8. Cosmeceuticals: How To Navigate The Legal And Regulatory Hurdles Of A Growing Market

    Laws and regulations differ greatly between drugs and cosmetics. Drugs must be submitted for FDA approval. Cosmetics are not. Product manufacturers should know what constitutes a legitimately clinically proven cosmeceutical, as well as what the FDA has to say about these cosmetic-drug hybrids.

  9. Changes to WHODrug Are Coming – Will You Be Ready?

    Why you should prepare now even with nearly a year remaining.

  10. From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments

    This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.