FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA seeks input on rare disease clinical trials network

To further the establishment of a rare disease clinical trials network, the US Food and Drug Administration (FDA) is asking for input from the...

USA – FDA looks to overhaul Orange Book, seeks input on patent listings

Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book, which lists patent, exclusivity and...

Canada – Health Canada releases guidance to streamline COVID-19 clinical trials

Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents...
FDA updates safety recommendations on biotin interference in lab tests

USA – FDA consults on ICH residual solvents update

The US Food and Drug Administration (FDA) on Tuesday launched a two-month public consultation on an International Council for Harmonisation (ICH) guideline establishing new...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – FDA updates COVID-19 compounding guidance with reporting clarification

Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among...

USA – Epinephrine and morphine added to FDA’s COVID-19 compounding lists

Two more injectable medications have been added to the US Food and Drug Administration’s (FDA) guidances on drugs that can be compounded by registered...

USA – FDA guidance targets adverse event reporting during trials

The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address...

USA – FDA updates clinical trial guidance for drugs, devices

The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address...

USA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including...

USA – Blood cancer candidates gain orphan tag from FDA

The FDA granted orphan drug designation to two therapies in development for hematologic malignancies.   Umbralisib (TG Therapeutics) received orphan drug designation for the treatment...

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