CATO Thought Leadership

CATO Thought Leadership

Webinar Series: Regulatory Pathway Strategies

 

  • New FDA Guidances for November and December 2019…
    by Cato Research on January 6, 2020 at 9:36 pm

    By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, […]

  • What’s New Health Canada? November 2019 Updates
    by Cato Research on December 20, 2019 at 2:41 pm

    By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: Biologics and Genetic Therapies Directorate: Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and […]

  • New FDA guidance on alternate approaches in…
    by Cato Research on December 20, 2019 at 2:09 pm

    By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) […]

  • New FDA Guidances for October 2019 and Upcoming…
    by Cato Research on November 6, 2019 at 3:09 pm

    By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research Special Interest Guidances/Information Date Posted Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019 Chronic Hepatitis D Virus Infection: Developing Drugs for […]

  • What’s New Health Canada? August and September…
    by Cato Research on October 18, 2019 at 1:19 pm

    What’s New Health Canada? By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate What’s New in: Therapeutic Products Directorate: Biologics and Genetic Therapies Directorate: Medical Devices: […]