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Regulatory Focus Articles RSS Feed 2.0
15 April 2021
Welcome to our European Roundup, our weekly overview of the top regulatory news across Europe.

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14 April 2021
More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines that currently have or will rece...
14 April 2021
Teleconferencing, livestreaming video and screen-sharing technologies are among the tools FDA says it will use when it determines that a remote interactive evaluation is appropriate for a particular facility.
14 April 2021
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
14 April 2021
Among the new moves: FDA plans to eventually revoke its approval of the widespread crisis-era practice of decontaminating N95 respirators and returning them to front-line workers to use again.
13 April 2021
The warning letters signal the agency’s increasing reliance on a review of records supplied by firms as investigators cannot get to sites in the midst of the coronavirus pandemic.  
13 April 2021
“In consultation with FDA, we tried a lot of these things like consent by phone and shipping oral [investigational new drug] medicines to the home, and they were wildly successful,” said Sharpless. “I think we’ve learned a lot of things that you d...
13 April 2021
Welcome to Asia-Pacific Regulatory Roundup, our weekly overview of the top regulatory news from the Asia-Pacific region.
13 April 2021
The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced a rare blood clot in combination with low blood platelet counts, or thrombocytopenia.   
12 April 2021
The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
12 April 2021
The US Food and Drug Administration held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially der...

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Communication of regulatory intelligence: A survey of the medical device industry Member only
08 April 2021
Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where ...