Industry Insights

  1. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

  2. 4 Critical CMO/CDMO Capabilities: Navigating The Evolving Contract Manufacturing Landscape 9/10/2024

    This comprehensive guide equips contract manufacturers with the tools to thrive in the ever-evolving life sciences industry. Read how to streamline and optimize your contract manufacturing operations.

  3. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  4. Telltale Signs You're With The Wrong CDMO

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  5. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

    The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

  6. Application Of A Novel Temperature Shift Process For Particle Engineering

    Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

  7. Global Market Outlook On Stem Cell Manufacturing 3/1/2023

    The stem cell manufacturing market is rapidly growing and is expected to grow from $11.22 billion in 2022 to approximately $23.89 billion by 2030. What are the key market drivers, restraints and challenges, and advancements to watch?

  8. How Can Genetic Tuning Expand the Reach of Genetic Medicine? 7/26/2023

    Epigenome editing, or genetic tuning, is an innovative molecular technology that fine-tunes the expression of genes to a therapeutically appropriate dosage, effectively expanding the reach of genetic medicine beyond the binary on-and-off switches of prior methods. Let's examine this more closely.

  9. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

    Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

  10. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.