Brand & Product Security

Videos

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar. 

HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Articles

Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.

HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

HDA 2024 Traceability Seminar: What to Expect From FDA Inspections

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain. 

HDA 2024 Traceability Seminar: DSCSA Implementation and Readiness

The agency provides an update surrounding the Act’s implementation efforts.

HDA 2024 Traceability Seminar: An FDA Perspective on DSCSA

The updated COVID vaccine replaces previous bivalent vaccines, focusing on a single strain for more effective immunity.

FDA Approves Updated Moderna, Pfizer COVID-19 Vaccines for Omicron KP.2 Variant 

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

Medicare Unveils Results of First-Round Drug Price Negotiations

In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.

Keeping Counterfeit Goods Out of the Supply Chain

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’  Senior Director of DSCSA/Serialization Compliance Services, predicts the likelihood of stabilization period postponement. 

Extending the Stabilization Period

What does the legislation mean for patient access leaders, pharma brand       managers, and patient service owners? Industry experts weigh in.


Legal & Regulatory