Keeping up to speed with the ever-changing global regulatory environment isn’t easy, but it’s vital when it comes to ensuring ongoing compliance. This section offers discussions of new or updated guidance, regulations, and standards.
The agency’s new two-phase regulatory framework seeks to strengthen domestic supply chain and reduce foreign dependence on active pharmaceutical ingredients.
The FDA recently issued a notice to pharma companies that drug applications with data from two clinical research organizations will no longer be acceptable.
While the R&D and clinical world has stayed on the cutting edge of modern medicine, the country’s manufacturing industry has slipped through the cracks of Australia’s economy...
