Legal and Regulatory

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

As companies seek interoperability across their organizations, a joint approach to medical information and local pharmacovigilance may deliver future benefits

Exploring new guidances and future challenges for pharma trading partners in meeting looming DSCSA mandates in the US

The pandemic has accelerated the adoption of enterprise resource planning in pharma supply chain management, as the recent US rise of one “technology enabler” attests

A dramatic shift to e-sampling has been the effective counter to the reduced number of rep visits to physicians’ offices

Recent FDA actions may finally usher in access boost to follow-on biologics in the US

FDA’s recommended guidance is for a system that ‘does not exist, cannot be built by 2023, and poses unacceptable security and compliance risks,’ says alliance

Plan aims to offset costs associated with proposed social and health initiatives

In-house center eliminates the need for a contract manufacturer, company says

Open-to-the-public workshops begin on July 28

Biden’s executive order targets drug pricing, healthcare costs and health insurance practices

Exploring RCT, RWE and alternative study designs as a path forward

Barcode assessment project demonstrates the ground gained in meeting serialization-readiness requirements for supply chain transparency

“Aggregation” and “inference” are specifically allowed, under draft guidance

Pair of life-sciences data powerhouses are immersed in dispute over their respective data services for pharma sales and marketing

The drive for “vaccine equity” around the world is strengthening efforts to limit patent protections on innovative drugs and vaccines to combat Covid

Proposal also points to need for further resource investment to “enhance” FDA operations

Pfizer is working with local law enforcement to counter the threat

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production