REGULATORY INSIGHTS

  • Clinical Labeling: Looking Ahead
    Clinical Labeling: Looking Ahead

    As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.

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REGULATORY MULTIMEDIA

  • Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access

    Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.

  • Development Advice For Gene Therapy Products

    This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development

  • Understanding FDA’s Priority Review Voucher System

    How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.

  • New Drug Application

    Marketing application submissions, including NDAs, biologics license applications (BLAs), and premarket approvals (PMAs) in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you navigate submissions in the most efficient and effective way.

  • 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.

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REGULATORY SOLUTIONS

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