Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting ...

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...

The move, highlighted on FDA@s mifepristone information webpage and in updates to an associated question-and-answer (Q@A) page on 16 December, makes permanent the eased restrictions permitted during ...

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical ...

COLUMBUS, OH @ Device recalls often take more than a year to complete, but device manufacturers can make that process smoother by providing regular status reports to the US Food and Drug ...

SILVER SPRING, MD @ Medtech industry stakeholders kicked off the latest round of medical user fee negotiations by stressing they want to ensure user fees supplement Congressionally appropriated ...

The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development ...

The regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues. From 2014 through 2016, various publications—from the Washington Post to Vox to ...

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty ...

Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world ...