FDA Finalizes Guidance on Advertising and Promotional Material Submissions

USA – FDA Finalizes Guidance on Advertising and Promotional Material Submissions

The US Food and Drug Administration (FDA) on Friday finalized guidance on the requirements and recommendations for submissions of promotional materials for prescription drugs...
New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD)

Canada – New regulatory activity types for filing to the Marketed Health Products Directorate...

This notice serves as a confirmation of the new regulatory activity (RA) types to be used in lieu of the Undefined Data Post-market Vigilance...
FDA program to respond to questions from stem cell therapy developers

USA – FDA program to respond to questions from stem cell therapy developers

The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers...
Iran, Argentina Join International Drug Regulators Group

USA – Iran, Argentina Join International Drug Regulators Group

Regulators from Iran and Argentina have joined the International Pharmaceutical Regulators Programme (IPRP) as members, the IPRP announced following its third management committee meeting...
FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

USA – FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency...
FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants

USA – FDA : Statement on a new effort to improve transparency and predictability...

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and...
FDA approves new treatment for pediatric patients with type 2 diabetes

USA – FDA approves new treatment for pediatric patients with type 2 diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes....
FDA, USP Clash Over Biologics Monographs

USA – FDA, USP Clash Over Biologics Monographs

While the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) work closely with one another on many issues, the two...
Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

Canada – Statement on the Investigational Use of Marketed Drugs in Clinical Trials

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada. It will serve as...

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