Regulatory Sciences

  1. What To Expect During The NDA Review Process 6/5/2024

    Read this article to gain a deeper understanding of the New Drug Application review process and what to expect.

  2. Challenges In Oncology Trials: How To Navigate The Evolving Regulatory Landscape 6/3/2024

    Explore how oncology clinical trials, specifically in targeted anti-cancer drug development, tackle the dynamic regulatory landscape.

  3. How A Strong Regulatory Strategy Supports Your Product's Success 6/3/2024

    Gain a deeper understanding of the importance of a strong regulatory strategy in meeting regulatory requirements, streamlining the development process, and minimizing risks.

  4. NDA Submissions 505(b)(1) Or 505(b)(2) 6/3/2024

    There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

  5. FDA Consulting: Regulatory Strategy Expertise 5/28/2024

    Streamline the time to market with a comprehensive FDA regulatory strategy that harmonizes product knowledge and wide-ranging expertise across diverse domains, guaranteeing a well-balanced approach.

  6. Regulatory Affairs Project Manager 5/28/2024

    Discover how a ProPharma consultant effectively integrated tools, streamlined processes, and enhanced communications within a biotech company to ensure regulatory filings would be delivered promptly and with the highest level of quality.

  7. 6 Key Elements Of Successful Drug And Device Development In Europe 5/28/2024

    Equip your team with the knowledge and strategies necessary to navigate the complexities of EMEA and country-specific regulations with confidence and clarity.

  8. Formal FDA Meetings For Sponsors Or Applications Of PDUFA Products 5/28/2024

    Consider this draft guidance regarding the conduct of formal meetings between the FDA and Sponsors, which aims to address issues related to the development and review of drugs and biological products.

  9. FDA's Expedited Programs Explained 5/28/2024

    By thoroughly understanding the unique aspects of each expedited program, learn how regulatory strategies can be tailored to better align with a product’s characteristics and the specific needs of the medical community.