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 ...

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 ...

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 ...

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 @ ...

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 ...

This article discusses how to estimate the probability of regulatory/registration success for pharmaceutical products in development. The authors define the factors and methods used to assess ...

The author discusses particle concentration for cleanrooms “at rest,” particle contamination in the air, start-up testing vs. routine monitoring, risk analysis and “interlocking” doors.

Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...

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 ...

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

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 ...