USA – FDA revokes EUA for hydroxychloroquine, chloroquine

The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) allowing the use of chloroquine phosphate and hydroxychloroquine sulfate...

USA – Experts address clinical challenges for ultra-rare diseases at BIO

A panel of experts at BIO Digital on Wednesday discussed some of the challenges and regulatory considerations for sponsors developing treatments for ultra-rare diseases...
New guidance on biologics affects authorized generics

USA – FDA releases compliance program for CDER, CDRH-led combination product inspections

In a newly issued compliance program, the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research...

USA – Fauci: US will have 100M doses of COVID-19 vaccine by year-end

The United States should have 100 million doses of one candidate coronavirus vaccine by the end of the year, Dr. Anthony Fauci, the director...

USA – GAO voices concern about FDA’s foreign drug inspection practices

A top official for the Government Accountability Office suggested the FDA is not adequately inspecting foreign drugmakers, leaving the U.S. drug supply chain vulnerable...

USA – FDA issues 69 new and revised draft product-specific guidances

The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic...
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...

NOS PROCHAINES FORMATIONS