Articles

Acquisition of AcKnowledge RS also expands company's IVD expertise

RQM+ furthers regulatory knowledge with consulting firm purchase

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

No slowing of approval train at FDA 

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

First Covid antiviral pill wins FDA authorization

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?

Ups and downs in the march to DSCSA compliance

Biden touts provisions administration believes can curb spending on pharmaceuticals

Drug costs central issue in budget battles

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

CSA a Game Changer for the Life Sciences?

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


Califf nominated to head FDA

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

Generic drugmakers also fight price controls

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

The pace of DSCSA readiness preparations has slowed, says annual HDA survey

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

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