The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

Why did you decide to get your RAC? Well, I wanted to move forward in my profession. And the RAC gave me the opportunity to review all the regulations from devices, drugs, biologics and other areas ...

Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on ...

The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...

Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The appointment, announced on Twitter Monday morning, ...

In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true ...

MDCG notes that it is up to national law to determine what professions qualify as authorized persons in any given jurisdiction. The document also clarifies some of the obligations of CMD manufacturers ...

The US Food and Drug Administration has updated information on compounding drugs during the COVID-19 pandemic, focusing on some specific compounded drugs related to COVID-19. “FDA has concerns about ...

Woodcock’s tenure at FDA began at the Center for Biologics Evaluation and Research (CBER) in 1986, where she held various division and office director-level roles before being promoted to CDER ...

Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the ...

A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing ...

The US Food and Drug Administration (FDA) has finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence process. The final ...