Regulatory Activity News Today

WASHINGTON, November 06, 2023--FISCALNOTE ANNOUNCES EXPANSION OF GLOBAL POLICY & ANALYSIS COVERAGE TO INCLUDE CHINA - Covers National, Provincial Legislative and Regulatory Policy

The Business Research Company’s Therapeutic Proteins Global Market Report 2023 – Market Size, Trends, And Global Forecast 2023-2032

On December 28, 2022, New York State Register published a summary of the New York State Office of the Medicaid Inspector General’s (“OMIG”) Notice of Adoption for Rulemaking on Medicaid...

Vaborem, a patented combination of meropenem and vaborbactam, is expected to address the rising prevalence of carbapenem-resistant Klebsiella pneumoniae (CRKP) infections in China The deal brings together Melinta's innovation, Menarini's cross-regional expertise in registration and marketing this asset, and SciClone's development and commercial presence in China Menarini will receive a total payment of up to 115 million, which includes milestone payments and tiered royalty on net sal...

/PRNewswire/ -- LexisNexis® Risk Solutions released the findings from a special edition of its Sanctions Pulse infographic focused on the sanctions that have...

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

January 14, 2021 In 2020, the COVID-19 pandemic taught the world another lesson about the unpredictability of life. Each country responded to the challenges posed by the pandemic in its own way. The German Government in its familiar technocratic and sober approach quickly unlocked massive financial resources to mitigate any immediate economic damage. It supported a further relaxation of the purse strings at EU level and put legislative acts in place that helped manage the uncertainty in the mos...

Guidance on submitting clinical trial safety reports How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). From: Print this page You must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways: If you intend to submit SUSARs using one of the new reporting routes, you must register. For trials ongoing in both the UK and in European member states dual reporting is...