ICH Guidance on Elemental Impurities

USA – FDA Finalizes ICH Guidance on Elemental Impurities

The US Food and Drug Administration issued final guidance Tuesday that explains when to conduct risk assessments for elemental impurities in drug products. The new...
Falsified Medicines Directive: Implications for parallel importers and of Brexit

Europe – Falsified Medicines Directive: Implications for parallel importers and of Brexit

Introduction to the Falsified Medicines Directive Directive 2011/62/EU, better known as “The Falsified Medicines Directive” or “FMD”, came into force on 2 January 2013, with...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – Biomarker Qualification: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Tuesday released draft guidance for industry discussing the recommended components of a biomarker development program, including...
ALCOOL : LE BACLOFÈNE OBTIENT SON AMM

France – ALCOOL : LE BACLOFÈNE OBTIENT SON AMM

Le directeur général de l'Agence nationale de sécurité du médicament (ANSM), Dominique Martin, a finalement tranché : le baclofène a obtenu son autorisation de mise...
Access our Canada medical device regulatory chart in RAMS

Canada – Bipartisan Bill would allow Drug Imports from Canada

Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) introduced legislation Wednesday that seeks to allow importation of drugs from approved pharmacies in Canada. The bill, called the...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India Advances Plan to Create Mobile Drug Testing Laboratories

ndia’s Drugs Consultative Committee (DCC) has backed plans to create mobile laboratories to test drugs around the country. The plans call for one mobile...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA issues final rule on OTC hand sanitizers

The FDA issued a final rule requiring OTC sanitizers with certain active ingredients to seek approval under an NDA or ANDA as a new...
Drugmakers Make Significant Headway in Track-and-Trace Compliance

USA – Drugmakers Make Significant Headway in Track-and-Trace Compliance

A new GS1 Healthcare report on the progress made in meeting the serialization requirements of the Drug Supply Chain Security Act (DSCSA) found significant progress, especially...
FDA final guidance targets competitive generic therapies

USA – FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment

In light of the need to act quickly and efficiently to respond to the COVID-19 public health emergency, the US Food and Drug Administration...

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