Legal & Regulatory

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, details the types of regulatory pressures and factors surrounding rising R&D costs that will affect the pharmaceutical industry.

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing why the pharma supply chain sees value in this technology and why its use has fluctuated over the past decade.

In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.

In this Q&A, Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications.

Albert Thigpen, co-founder, Talentwise Consulting, discusses the valuable buckets pertaining to the PBM space.

Albert Thigpen, co-founder, Talentwise Consulting, offers highlights of the drug commercialization panel that he participated in.

With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

A deep dive into the future of patient service programs and the value of transparency throughout the process.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, explains how pending legislation can improve patient access, and how these are helping with recognizing pharmacists as HCPs.

Getting a handle on level of compliance-readiness for the Drug Supply Chain Security Act deadline—now just weeks away.

Webinar Date/Time: Tue, Oct 22, 2024 11:00 AM EDT

As the dust settles on the first round of Medicare negotiations, not everything is what it seems.

The session details how these teachings span the entire pharma supply chain.

A panel offers its perspective on bolstering the temperature monitoring and data sharing process.

With the Nov. 27 deadline fast approaching, is the pharma supply chain ready for full data exchange?

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

FDA fast tracks Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis knee pain, with Phase III clinical trials planned to expedite a potential approval.

It’s essential for commercial success, but presents its share of obstacles.

A cross-sectional study investigates changes in Medicare Advantage enrollment among Medicare beneficiaries with end-stage renal disease in the first two years of the Act.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.

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.