Clinical Supply Regulatory Articles

1. Who Pays For The Comparator? Insurance Cost-Sharing And The Wall That Got Taller 11/11/2026

   Insurance cost-sharing could reduce clinical trial comparator expenses, but federal coverage rules and anti-kickback restrictions create significant challenges for sponsors.

2. Sourcing Through The Tariff Mess: What 2026 Actually Means For Clinical Supply 11/6/2026

   US tariff changes are reshaping clinical supply sourcing. Learn how pharmaceutical duties, country-of-origin documentation and temporary import provisions affect trial materials.

3. Beyond The Checklist: Auditing Clinical Supply Export Compliance 11/4/2026

   Auditing clinical supply export compliance means testing shipment controls, restricted party screening, technology transfers, and partner oversight to prevent risks and delays.

4. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

   FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

5. Policy Is Redefining Clinical Trials. Clinical Supply Must Respond. 10/23/2026

   Clinical trial policy is shifting research closer to patients, creating new demands for forecasting, distribution, inventory, accountability, cold chain, and cross-functional planning.

6. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

7. Clinical Trial Supply In The EU And U.K.: A Regulatory Guide 10/20/2026

   EU and U.K. clinical trial rules are evolving separately. Here’s what sponsors need to consider across QP release, labeling, importation, and supply continuity.

8. When Drug Supply Has A Half-Life: Radiopharmaceutical Logistics 10/1/2026

   Radiopharmaceuticals turn time into a supply-chain constraint. Short half-lives, patient scheduling, scarce radionuclides and regulatory differences reshape trial logistics.

9. Segregation Of Duties: Drug Accountability Needs Three Separate Roles 9/28/2026

   When one person orders, receives, and reconciles investigational product, a critical control disappears. See how role separation can strengthen drug accountability.

10. Before The Excursion: The Governance Decisions That Should Already Be Made 9/24/2026

    Temperature excursions are inevitable. The real risk is the time lost deciding what to do. See how preplanned governance can turn long quarantines into routine events.