Senators Bernie Sanders (I-VT) and Angus King (I-MN) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in ...

Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...

The European Union's medicines regulator on Friday granted a conditional authorisation for Madrigal Pharmaceuticals' drug for ...

Biotechnology and pharmaceutical industry professionals turn to digital microscopy for consistent and efficient electronic ...

SutiSoft leads the way in providing intelligent, cloud-based solutions that transform how businesses operate in a digital ...

But experts say the FDA should have no illusions regarding the unreliability of such surrogate outcomes, especially since these outcomes fail to take into account the harms a drug may cause, such as ...

Ordinarily, the holder of an approved new drug application (NDA) or an approved abbreviated new drug application (ANDA) must ...

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some ...

FDA Unveils Transparency Tool for Easy Check of Contaminant Levels in Foods By Stephanie Brown HealthDay Reporter FRIDAY, March 21 ... reference (e.g., Code of Federal Regulations, FDA Guidance ...

In reality, supplies of the drug—and related deaths—have sharply ... Fatal overdoses have dropped nationwide by more than 21 percent since June 2023, data from the U.S. Centers for Disease ...