Govt considers random testing of imported medical devices (24-09-2024) ...

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...

The FDA reached a significant milestone when it approved its reorganization and created its new unified Human Foods Program ...

In the US, for example, the FDA now provides the opportunity for ... A strategic partner Regulatory affairs as a function has undergone a significant shift in its strategic role and impact over ...

There hasn’t been a new class of drugs approved to help smokers quit since Pfizer's Chantix reached the market nearly two ...

What key compliance considerations should pharma companies keep in mind before releasing new research in the US market?

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting, the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson ...

Select FDA Patent Term Extension Application for OGSIVEO™ (nirogacestat hydrobromide), Patent No. 7,951,958 FDA-2024-E-0434 Select FDA Patent Term Extension Application for OGSIVEO™ (nirogacestat ...