Simplifying Global Compliance

Recommended Products

EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

Accelerating-generic-drug-development-130x160

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

Home » Topics » Pharmaceuticals » Postmarket Safety

Postmarket Safety
RSS

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

December 12, 2017

Of the 1,323 postmarketing requirements (PMRs) open by the end of fiscal 2016, 84 percent related to NDAs. Read More

EMA’s New EudraVigilance System Goes Live

December 11, 2017

The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More

EMA Publishes Q&A on Periodic Safety Update Reports

December 11, 2017

The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

December 8, 2017

Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Read More

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

December 5, 2017

The PRAC confirmed its September recommendation that extended-release paracetamol pain relievers be removed from the market. Read More

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

December 1, 2017

The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More

FDA Warns of Undisclosed Drugs in Weight Loss Supplement

November 28, 2017

The agency said the product is part of a “growing trend” of undisclosed ingredients in dietary supplements. Read More

EMA’s New EudraVigilance System Goes Live

November 22, 2017

The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More

FDA Unveils New Public Dashboard for its FAERS Database

November 20, 2017

The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More

EMA Answers More Stakeholder Questions in Lead Up to EudraVigilance Launch

November 20, 2017

The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the launch of its new EudraVigilance drug safety reporting program. Read More

EMA Publishes Q&A on Periodic Safety Update Reports, Previews Possible GVP Update

November 17, 2017

The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More

EMA Maps Steps for Improving Product Information for Patients

November 15, 2017

The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA
Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Recommended Products

EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Events

The Future of Generic Drug Competition: Deconstructing FDA and Congressional Initiatives

The Age of eSource: Modernizing Clinical Trials

Building a World-Class Advertising and Promotion Review Program

Pharma Regulation in 2020: FDA Priorities in the Upcoming Election Year

Implement a Best Practice Medical Device Change Control Process: Avoid Common Pitfalls

Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

Editor's Picks

Texas Device Manufacturer, Sterilizer Draws FDA Warning Letter

SK Life Science’s XCOPRI Approved for New Treatment for Adults With Partial-Onset Seizures

Postmarket Safety
RSS

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

EMA’s New EudraVigilance System Goes Live

EMA Publishes Q&A on Periodic Safety Update Reports

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

FDA Warns of Undisclosed Drugs in Weight Loss Supplement

EMA’s New EudraVigilance System Goes Live

FDA Unveils New Public Dashboard for its FAERS Database

EMA Answers More Stakeholder Questions in Lead Up to EudraVigilance Launch

EMA Publishes Q&A on Periodic Safety Update Reports, Previews Possible GVP Update

EMA Maps Steps for Improving Product Information for Patients

Recommended Products

Events

Editor's Picks

Postmarket Safety RSS

Postmarket Safety
RSS