Legal & Regulatory

In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

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.

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

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.

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

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

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

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%.

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.

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.

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

Will the looming changes address the concerns of the patient assistance community?

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the Drug Supply Chain Security Act, along with opportunities for improvement.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, offers a brief overview of the Drug Supply Chain Security Act.

Why they are a game changer, and ways to a adapt to a new era of state privacy regulations.

With the standard constantly evolving across the pharma sector, the latest version can help bring benefits to the regulatory process.

If Congress doesn't act soon, it could result in more health inequities.

These advancements continue to act as a key driver in helping to boost the security, efficiency, and innovation of global industries, include pharma.

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the pharma industry.

Study explores how the Inflation Reduction Act’s Drug Price Negotiation Program and its maximum fair prices impact incentives for investments in post-approval activity.

The partnership revolves around augmenting regulatory compliance, along with drug sampling distribution and compliance.

Citing a need for more Chemistry Manufacturing and Controls information, Abeona intends to address the requirements quickly.

Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

Data displayed rapid and sustained B-cell depletion, with 97.2% of study patients with relapsing and primary progressive multiple sclerosis experiencing no relapses.

Data from the Phase III APPLAUSE-IgAN study showed a 38.3% reduction in proteinuria in patients treated with Fabhalta for IgA nephropathy compared to placebo.

Phase IIa clinical trial of SPG60 for Fragile X syndrome offers hope for disease with no current FDA-approved treatment options.