Featured Pharma Online Editorial

1. FDA Publishes Guidance For Biopharma Container And Carton Label Design 6/13/2022

   The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

2. EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance 12/28/2021

   With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

3. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

   The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

4. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

   Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

5. How To Find & Manage Biotech Consultants Effectively 9/6/2021

   The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

6. What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

   When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

7. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

   Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in. 

8. Establishing An Effective Calibration Program 3/15/2021

   Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

9. 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement 1/6/2021

   This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

10. Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? 10/5/2020

    The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.