New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials ...

The US FDA is currently reviewing its pharmaceutical manufacturing Guidance, after receiving feedback from industry trade groups. What will the new Guidance mean for pharma companies, as well as ...

Leadership in statistical programming is about more than managing deliverables—it’s about inspiring teams and exceeding ...

Vietnam is aiming to attract overseas investment to encourage domestic drug development through the amended 2016 Law on ...

The Trump administration, perhaps surprisingly, chose to defend the legality of the Inflation Reduction Act’s (IRA’s) drug ...

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year ...

Event featured insightful discussions on key regulatory topics as well as focusing on drug safety and procurement strategies ...

The 21st century pharmaceutical ... return on investment for drug manufacturers, solidifying the incentive to invest in new medicines. The US pharmaceutical industry was booming, thanks to being ...

India's drug regulator plans to streamline export clearances and simplify manufacturing licensing to reduce workforce burden.

The lawsuit, filed in Fort Worth, Texas federal court by the Outsourcing Facilities Association, a compounding industry ... The FDA declined to comment on the lawsuit. U.S. regulations allow ...

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. is seeking to eliminate public participation in many of his ...

A legal dispute over tirzepatide’s availability is reshaping diabetes and weight loss treatment access, raising concerns for ...