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Regulatory Focus Articles RSS Feed 2.0
16 April 2021
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) after its initial standardization request was...

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16 April 2021
As part of an ongoing focus on rare diseases, FDA and industry discussed a proposed pilot program to identify novel endpoints for rare diseases, envisioning “potentially a limited number of common disease programs with innovative endpoints that ha...
16 April 2021
Updated 16 April to include new information on baricitinib, dexamethasone, Veklury, MK-7110, Farxiga, casirivimab/imdevimab, bamlanivimab, bamlanivimab/etesevimab and mavrilimumab.
15 April 2021
The US Food and Drug Administration (FDA) on Thursday took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration.
15 April 2021
Updated 15 April  with new information on vaccines from Pfizer/BioNTech, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, Russian Federal Budgetary Research Institution State Research Center of Virology and Biotechn...
15 April 2021
In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.
15 April 2021
An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits and the risks of potential COVID-19 treatments and outlined ways to ensure the integrit...
15 April 2021
Welcome to our European Roundup, our weekly overview of the top regulatory news across Europe.
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).

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The PhD scientist’s pathway into regulatory affairs Member only
16 April 2021
Making a transition from a life and health science research scientist to regulatory affairs professional can be chall...