Articles by John Giantsidis

1. New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials 4/1/2024

   In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.

2. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

   The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

3. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

   The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

4. FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations 3/8/2022

   Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.

5. The Clinical Trial Sponsor's Roadmap To Avoid EMA (Cyber) Perdition 3/1/2022

   Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.

6. Are You Ready For The FDA's “Data Effect” Tsunami? 8 Steps To Prepare 5/5/2021

   The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.