Industry Insights

1. The Digital Health Tsunami Is Here. How Is FDA Gearing Up? 4/19/2018

   The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?

2. Addressing 3 Challenges Using The Tablet Press Automatic Weight Control System 7/20/2023

   Three serious issues have arisen in using tablet press automatic weight control systems. For example, we may encounter excessive start-up sampling when manufacturing small batch sizes, resulting in exceeding the maximum allowable loss and triggering an investigation. This expert discusses this point and two other issues.

3. Scaling Personalized Medicines For Flexible Aseptic Filling 2/14/2024

   Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.

4. Why We Shouldn't Be Categorizing Digital Therapeutics As Drugs 8/2/2021

   Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.

5. Standardizing Best Practices For Transporting Cell And Gene Therapies 2/16/2022

   Methodologies from a distribution standpoint had to be redeveloped to be significantly more rigorous, eliminating those allowances for time out of environment (TOE) and similar criteria.

6. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

   ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

7. Considerations For Drug-Device Combination Products In Rare Diseases 8/7/2025

   The development process for these products is complex, requiring careful consideration of regulatory requirements, technical feasibility, clinical efficacy, and patient-centered design.

8. Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices 3/2/2020

   This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

9. Leveraging Target Product Profiles To Optimize Portfolio Potential 8/8/2022

   This guide discusses the critical role of target product profiles (TPPs) in product development and offers tips and best practices for integrating these tools into and across programs to optimize portfolio potential.

10. Will We Have Harmonized Standards By The MDR's Date Of Application? 7/22/2019

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?