Legal & Regulatory

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

For pharma companies, an investment in a digital risk management tool is worth considering if they want to meet the European Union's regulatory requirements for pharmaceutical transport and wholesalers

FDA’s Unapproved Drug Initiative (UDI) is a well-intentioned program in its encouragement of formal FDA review for unapproved legacy medications. But it has inadvertently created financial challenges and access issues, write Steven Lucio and Jenna Stern

From November 2023, the Drug Supply Chain Security Act requires healthcare manufacturers, distributors, providers, and dispensers to exchange the serialized item-level product information that has been collected, standardized, and digitized. Hitting this deadline hinges on intensive collaboration between manufacturers and their supply chain partners that must begin now

Trading partner Interconnections via the EPCIS standard is a basic requirement

It has become critical to provide real-time accurate labeling information to labeling teams and healthcare providers as soon as a product change is approved by regulators. IQVIA‘s Cham Williams discusses the technology needed to support this shift and how these new solutions will minimize risks associated with regulatory compliance and increase patient safety.

GTS improvements include additional data integrity protection, greater Level 1 and 2 equipment compatibility

Publication finds that only about 40% of retail pharmacists feel equipped to discuss biosimilars with patients

The solution is a combination of cold chain logistics, serialization compliance and distribution

Software firm merges with PharmaLex Group

Action offers the fulfillment of a critical part of the Drug Supply Chain Security Act (DSCSA)

Grows Syner-G’s presence in RTP, a biotech hub that continues to develop

Following a November FDA public meeting, HDA reiterates the objections it had to guidance FDA issued in mid-2021 under the Drug Supply Chain Security Act (DSCSA)

Merger with Phlexglobal expands provider’s technological capabilities

In a civil action, Gilead alleges an extensive, transnational counterfeiting ring of HIV and other drugs

Acquisition of AcKnowledge RS also expands company's IVD expertise