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06 May 2021
A key organizer of RAPS’ Euro Convergence 2021 speaks to what’s new this year, how the conference is approaching hot-button topics in the EU regulatory space and how first-time attendees can maximize their experience during the live, virtual event.

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01 May 2021
Forward-thinking companies see the new regulation as an opportunity to harmonize and modernize processes and technology to gain market advantage.
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01 May 2021
As the volume of information continues to increase in the age of information overload, medtech companies face compliance risks in continuing to operate with manual and/or siloed systems that could disrupt their ability to effectively deliver compl...
06 May 2021
Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines...
06 May 2021
To support the development of therapeutics for COVID-19, the European Commission on Thursday announced a new strategy intended to bring at least three to five new COVID-19 therapeutics to market this year.
06 May 2021
RAPS will hold its annual RAPS Euro Convergence conference devoted to European healthcare product regulations and regulatory issues, 10–12 May. This year’s program will feature more than 130 expert speakers and more than 40 educational sessions ta...
06 May 2021
Updated 06 May with new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm and Bharat Biotech as well as vaccine candidates from Novavax, Biological E, Valneva an...
06 May 2021
Welcome to our European Roundup, our weekly overview of the top regulatory news across Europe.
05 May 2021
A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.
05 May 2021
Although there have been fewer spikes in drug prices between 2014 and 2017, “price spikes remain common among injectable drugs, drugs with three or fewer manufacturers, and drugs facing shortages.” About 1 in 5 generic drugs have doubled in price ...
05 May 2021
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
05 May 2021
Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Eval...
04 May 2021
The inactivated, adjuvanted Vero cell vaccine, known as Coronavac, joins three others that are in EMA’s rolling review process, which allows sponsors to add to the candidate vaccine’s portfolio as data accrue.