RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

      RAPS COVID-19 Resource Center


RAPS continues to monitor the on-going Coronavirus pandemic and has compiled the following resources to help you stay informed on this rapidly evolving situation. Please check back regularly for updates and to learn more about special programs RAPS has available to support you and your professional development during this difficult time.

Please visit our public safety page for the updates to RAPS policies and procedures in response to COVID-19.
 

Highlighted Resources

COVID-19 Therapeutics Tracker

Stakeholders are looking to repurpose approved drugs that have worked against similar coronaviruses in the past or are hypothesized to attack or immobilize SARS-CoV-2 based on the mechanism of action.

This tracker will be updated weekly with the latest in developments for these treatment candidates.

COVID-19 Vaccine Tracker

Experts estimate it could take between 12-18 months to develop a vaccine ready for market, which assumes the process from conception to market availability goes smoothly.

This tracker lists the major vaccine candidates in development for prevention of COVID-19

A New Way to Stay Connected

In response to these challenging times, our RAPS Chapters have converted their regular in-person events to virtual webcasts that are free with your membership.

Explore different regulatory communities and topics while benefiting from the collective knowledge of the full RAPS chapter network.

MedBoard COVID-19 Tracker

MedBoard has developed a COVID-19 tracking webpage that collects all of the regulations, guidance and notices related to medical devices and in vitro diagnostic products (IVDs) and the keywords: 'covid-19', 'sars-cov-2' and 'coronavirus'.

This tracker is updated daily.

EMBL-EBI COVID-19 Data Portal

EMBL-EBI has launched the COVID-19 Data Portal to bring together relevant datasets for sharing and analysis in an effort to accelerate coronavirus research. It enables researchers to upload, access and analyze COVID-19 related reference data and specialist datasets as part of the wider European COVID-19 Data Platform.

 

Special Offers

New York/New Jersey Chapter Webcast: OTC Monograph Reform Amongst the COVID Economic Recovery Package

Learn about key elements of the CARES Act and how current and future OTC products may be affected.

MEMBERS - FREE
NONMEMBERS - $20
DATE: 27 May at noon ET

Update: Implications to Life Science Companies Relating to COVID-19

Our experts explain what is required during the COVID-19 crisis.

MEMBERS: FREE
NONMEMBER: $20.00 FREE until 15 July 2020

Implications to Life Science Companies Relating to COVID-19

Learn how COVID-19 changes will impact market entry to both the US and China.

MEMBERS: FREE
NONMEMBER: $20.00 FREE until 15 July 2020

Ethics — Essential Tools for Regulatory Professionals

Learn the importance of doing the right thing when product quality is at risk.

MEMBERS: $465.00
NONMEMBERS: $640.00

FREE until 15 July 2020

Business & Leadership Collection

RAPS is opening up this collection of on-demand webcasts to support your professional development during this difficult time.

Nonmembers will need to create a login to view the webcasts.

FREE until 15 July 2020

Regulatory Focus™ Articles

 

UK grants early access to remdesivir for COVID-19

Posted 26 May 2020 | By Michael Mezher 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the ...

EMA strengthens ENCePP mandate to address COVID-19 pandemic

Posted 26 May 2020 | By Kari Oakes 

The European Medicines Agency (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), creating a COVID-19 Response Gro...

FDA warns Seattle-based company for marketing COVID-19 vaccine

Posted 22 May 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Thursday warned Seattle-based firm North Coast Biologics for marketing an unapproved vaccine for SARS-CoV-2, the...

COVID-19 therapeutics tracker

Posted 22 May 2020 | By Jeff Craven 

This week's update includes new information on remdesivir, otilimab, ivermectin, acalabrutinib, hydroxychloroquine and lenzilumab.

COVID-19 vaccine tracker

Posted 22 May 2020 | By Jeff Craven 

This update includes Phase 1 data from Moderna; additional updates from 14 May include new information on vaccine candidates from Sinovac, Symvivo, NovaVax, Vaxart and Takis Biotech. 

FDA issues guidance on PMA, HDE supplements amid COVID-19

Posted 21 May 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submittin...

MHRA launches dedicated COVID-19 Yellow Card site

Posted 21 May 2020 | By Kari Oakes 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday launched a dedicated site for reporting side effects and incidents related to medicines and medical devices used...

Multinational efforts build framework for real-world and observational COVID-19 data

Posted 21 May 2020 | By Kari Oakes 

International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic.  

EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine

Posted 21 May 2020 | By Nick Paul Taylor 

Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment.

FDA names companies removed from antibody test list

Posted 21 May 2020 | By Michael Mezher 

After tightening its oversight of antibody tests for coronavirus disease (COVID-19) earlier this month, the US Food and Drug Administration (FDA) on Thursday began publicly listing commercial ...

COVID-19 Public Health Resources

Access links to specific COVID-19 government resources from around the globe:

 

Engage with RegEx Discussions

Reach out to collaborate with your peers and colleagues in the RAPS Regulatory Exchange community, and stay connected anytime, anyplace with our new RegEx mobile app.

Join active coronavirus threads on the RAPS membership community.