Featured Pharma Online Editorial

1. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

   Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

2. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

   The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

3. Lilly's Calculated Approach To Upgrade Trade-Offs 5/22/2025

   If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.

4. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

   The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

5. ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy 5/12/2025

   Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

6. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

   When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

7. Oral Therapies Take Center Stage For PsO And PsA Treatment 4/1/2025

   The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.

8. AI Model Cards Make Function And Risk Easier To Understand 3/31/2025

   AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

9. The Technologies Propelling GLP-1 Analogues 3/18/2025

   This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.

10. Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product 3/10/2025

    Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.