Legal & Regulatory

Micah Litow, Kalderos’ president and COO, discusses the importance of identifying and resolving noncompliant discount requests, along with addressing the gross-to-net gap for drug manufacturers.

The legislation’s deadline for compliance is knocking on the door. Pharma Commerce offers a synopsis of how the Drug Supply Chain Security Act has progressed over the past decade.

Forces pharma giant to hand over marketing communications with Meta.

Pharma company claims that the IRA’s drug pricing clauses violate the First and Fifth Amendments.

New PC column explores commercialization trends and how pharma can adjust to the new squeeze of market, regulatory, pricing, and gross-to-net pressures.

Latest Q4 2022 results show some progress, but 100% readiness by November looks doubtful.

New federal law introduces significant changes in the design of pharmacy benefit plans with aims to level the playing field between PBMs and their employee healthcare benefit plan clients.

“Deep learning” IT tools were used to calculate sales volumes and drug class.

Innovation and investment in advancing lifesaving therapies for pediatric patients to the commercial stage remains a daunting task, but rapid advances today in modeling and simulation are reducing the hurdles for drugmakers.

As a November deadline looms for industry compliance with an interoperable system for product tracing, there is more urgency in the US pharma supply chain.

Senate committee report highlights a lack of visibility in API suppliers.

Industry is still scrambling to handle clerical errors of DSCSA transactions.

Event—taking place in Indianapolis—places supply chain education at the forefront.

The Pulse online service will provide free resources to enable pharmacy to meet drug traceability rules.

Initiative intends to facilitate regulatory compliance within the pharma distribution space.

Meanwhile, PDG issues more DSCSA guidance on data interoperability.

Citing FDA’s slow guidance, the American Pharmacists Association is requesting delay in November 2023 DSCSA enforcement.

How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information

While this concern is causing ripples in the global supply chain, technological and regulatory advances can help address the issue

Wholesalers continue to worry about manufacturer commitment to timely compliance

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape

Allows CDMO’s regulatory, consulting services to further expand into the pharma market

Law firm to feature life sciences practice in New Jersey and Philadelphia

Innovation in pharma manufacturing as paradigms shift and biotech and personalized therapies move through clinical trials at pace

Location expands company’s pharmacovigilance, regulatory affairs services

Partnership adds technological offerings to PharmaLex’s repertoire

As a result of the United States Supreme Court’s overturning of Roe v. Wade and Planned Parenthood v. Casey, pharmacy providers are looking to state laws and other recently issued federal guidance in determining how they can compliantly meet patient needs and deliver medications.

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own

Faster approvals, more accurate and timely medicines monitoring—all enabled by harmonized, consistent and reliable data—will drive improved patient outcomes.

The EPCIS communications standard is “recommended,” and trading partners are identified