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Regulatory Focus Articles RSS Feed 2.0
24 November 2020
Health care workers would be among the first to receive vaccines against COVID-19 in a timeline presented to the Centers for Disease Control and Prevention’s (CDC’s) vaccines advisory committee. The proposed scheme would have essential workers nex...

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20 September 2020
Is your clinical trial data “submission-ready”?  Make the right decisions for your data to prevent delays.
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01 September 2020
Submitting your NDA on time is critical. Learn how to overcome timeline challenges with this success story.
Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to inc...
Guidance from the Indian Department of Pharmaceuticals clarifies how companies can take advantage of an order intended to encourage the use of local suppliers of medical devices.
The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management
The US Food and Drug Administration (FDA) on Monday launched a new cloud-based submission portal for orphan drug designation requests, shifting away from the current paper and CD-based submission process.
Updated 23 November to include the US FDA emergency use authorization of casirivimab and imdevimab (REGN-COV2).
23 November 2020
Updated 23 November  with new information on the vaccine candidate from AstraZeneca/University of Oxford. 
20 November 2020
With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EU...
20 November 2020
The current guidance drills down on recommendations for metabolism-based drug interactions with combined oral contraceptives, which usually contain two synthetic steroid hormones – a pr...
20 November 2020
In response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance...
20 November 2020
In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling ...