Legal & Regulatory

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

The Health System Owned Specialty Pharmacy (HOSP) Alliance‘s Melissa Goff responds to the news of the FTC investigation into PBM practices news and outlines the alliance‘s vision for the integrated specialty pharmacy industry

Features an ATP solution to allow for efficiency

IQVIA’s Jens-Olaf Vanggaard discusses the challenges of managing regulatory intelligence on a global scale.

The clock is ticking on a massive effort to bring interoperable, electronic tracking of pharma shipments in the US

A recommended checklist for manufacturers as they enlist distributor and 3PL support—and the important questions they should be asking themselves

Pressure is mounting ahead of looming unit-level serialization required by the Drug Supply Chain Security Act—necessitating a wide scope of collaboration on compliance

Outlining the work of the Open Credentialing Initiative in establishing digital proof of identity, licensure status, and authorship using digital wallets and verifiable credentials

After years of preparation, the European Union will be the first to adopt the Identification of Medicinal Products (IDMP) standards in 2023. Robin Schilling identifies three critical steps life sciences organizations can take toward a full-proof strategy that supports the changing regulatory requirements