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Canada – Performance Standards for the Fees in Respect of Drugs and Medical Devices...

The purpose of this document is to provide the performance standards to be used to determine whether a remission should be granted, under the Fees...

USA – Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance

The purpose of this guidance is to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis...

USA – FDA finalizes insanitary conditions guidance for compounders

Eight years after a fungal meningitis outbreak linked to the New England Compounding Center killed dozens of patients across the country, the US Food...
FDA Seeks Help Using Algorithms to Detect Adverse Event Anomalies

USA – FDA Seeks Help Using Algorithms to Detect Adverse Event Anomalies

As it becomes more difficult for the US Food and Drug Administration (FDA) to decipher when a series of adverse events could actually be...

USA – Guidance : Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in...

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic....
Pharmaceutical industry groups and Canadian pharmacists staunchly opposed the US plan to allow states and drug companies to import certain

USA – Drug industry groups oppose FDA’s drug importation plan

Pharmaceutical industry groups and Canadian pharmacists staunchly opposed the US plan to allow states and drug companies to import certain prescription drugs from Canada and other...

USA – ANDA consolidation process updated in new MAPP

The US Food and Drug Administration (FDA) has updated its manual of policies and procedures (MAPP) for the review of requests to consolidate previously...
EC Publishes New Guidelines on Good Clinical Practices for ATMPs

Europe – EC Publishes New Guidelines on Good Clinical Practices for ATMPs

Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical...
Determining Whether to Submit an ANDA or a 505(b)(2) Application - Guidance for Industry

USA – Guidance : Child-Resistant Packaging Statements in Drug Product Labeling

INTRODUCTION This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) statements in their...

USA – Moderna’s COVID-19 vaccine enters pivotal phase 3 trial

Moderna and the US National Institutes of Health (NIH) are collaborating on the late-stage COVE trial, which will evaluate the vaccine in 30,000 study...

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