Regulatory Affairs Editorial

  1. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

  2. Informed Consent In Clinical Trials: Understanding The FDA's And OHRP's Joint Draft Guidance 3/18/2024

    The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.

  3. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

    Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

  4. Supplying Complex, Controversial, And Intercontinental Clinical Trials 3/13/2024

    Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.

  5. Debra Weiss, RN: Big Impact In Small, Non-Profit Bio 3/8/2024

    The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.

  6. Navigating China's Biologics Approval And Accelerated Pathways 3/8/2024

    Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.

  7. Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov 3/5/2024

    The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting of trial results.

  8. FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

    On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

  9. 4 Drug Development Strategies To Accelerate Commercialization 2/24/2024

    Given the extenuated clinical trial timelines, every chance to shave off time, save money, and obtain regulatory approval is one worth taking. Discover four ways to accelerate your therapy’s path to commercialization.

  10. The FDA Speaks Up For Quality Management: Must They Beg? 2/20/2024

    The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents (listed below), and one global pandemic later, why aren’t we moving forward at more than a snail’s pace?