Regulatory compliance adds a major layer of operational complexity. Pharmaceutical supply chains must comply with stringent ...
The pharmaceutical industry has expressed strong opposition to the government’s push for drug price reductions, warning that such a policy—combined with rising oil prices, exchange rates, raw material ...
Virginia attracted $12 billion in pharmaceutical manufacturing investments in 2025, leveraging site readiness, workforce training, and strong infrastructure.
This article explores current OSD development and manufacturing trends from a CDMO perspective, including the evolution of ...
In May 2025, the Trump administration issued an executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” directing the Food and Drug Administration (FDA) and the ...
On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA ...
The pharmaceutical industry is engaging in a flurry of biotech deals and shifting clinical trials to China. It does so at a time when the U.S. is distancing from China.
President Donald Trump is slated to impose tariffs on pharmaceuticals imported into the U.S. any day now – and the duties may have a bigger impact on some drugmakers than others, according to some ...
In the opening remarks, Michael Kopcha, Director of the Office of Pharmaceutical Quality (OPQ), offered CDER’s perspective on advanced manufacturing and pharmaceutical quality. He began the ...