Center for Excellence in Drug Safety and Pharmacovigilance

Global Regulatory News

 

CEDSPV is your one stop source for staying on the cutting edge of global regulatory developments relating to drug safety and pharmacovigilance.

Additionally, as global politics impact legislation affecting DS &PV, Center for Excellence in Drug Safety and Pharmacovigilance is your source for staying current on all the latest happenings in Washington and political capitols around the world.

 

Something new on the Global Drug Safety Politics and Regulatory News horizon that we’ve left out ? Drop us a note at Team@CEDSPV.Com and we’ll be on it right away.

 Drug Safety and Pharmacovigilance Draft Guidances – US

Drug Safety Information-FDA’s Communication to the public

This draft guidance seeks to provide information on CDER’s process for communicating important new safety information to the public that may affect the product’d benefit risk ratio and/or information regarding prescribing or taking the drug.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295217.pdf

Thoughts on this draft guidance ?  Please comment below.

 

Classifying Significant Postmarketing Safety Issues

This draft guidance seeks to provide information on CDER’s process for prioritzing emerging safety issues into categories that allow the organization to determine where its limited resources should be applied most urgently.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295211.pdf

Thoughts on this draft guidance ?  Please comment below.

 

Something new on the Global Regulatory News horizon that we’ve left out ? Drop us a note at Team@CEDSPV.Com and we’ll be on it right away.