Legal & Regulatory

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

Pandemic notwithstanding, the agency maintained a steady pace in 2021 in clearing important new therapies, including new vaccines and drugs for Covid

Emergency-use clearance of Pfizer drug a major milestone in the fight against the now-omicron-fueled virus in the US

Building a data-sharing system for the US Drug Supply Chain Security Act (DSCSA) is two years from a mandated completion—will industry be ready?

Biden touts provisions administration believes can curb spending on pharmaceuticals

Exploring the FDA’s latest proposed guidance on computer system validation, and the movement toward a less burdensome approach

White House announces official endorsement, paving way for Senate confirmation process

It’s not just innovator pharma companies concerned with the proposed compromise to Medicare price negotiations and inflation-based rebates

Respondents: Pharmacies are still lagging in the compliance requirements that will be in effect in November 2023