USA – FDA seeks input on genotyping for pediatric codeine use

The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to...

USA – FDA gives Project Renewal update at AACR

Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress...

USA – FDA finalizes bacterial pneumonia drug development guidances

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both...
New guidance on biologics affects authorized generics

USA – FDA program to share patient-reported outcomes in cancer drug trials

The U.S. Food and Drug Administration announced a new pilot program Tuesday to share information on symptoms patients report while undergoing clinical cancer drug...
ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program

Brazil – Brazil to launch human trials of Oxford’s COVID-19 vaccine

Brazil is likely to sign a contract this week to produce a trial vaccine developed by Oxford University to guard against the novel coronavirus,...

USA – FDA: Follow CDC guidance for COVID-infected employees

A new guidance from the US Food and Drug Administration clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their...

USA – FDA officials update on orphan drugs, gene therapies at DIA

Officials from the US Food and Drug Administration (FDA) discussed the agency’s recent efforts to support the development of products to treat rare diseases...

USA – FDA guidance offers statistical advice for clinical trials

The US Food and Drug Administration (FDA) on Wednesday issued immediately effective guidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial...

USA -First patient-focused drug development guidance released

Final guidance for drugmakers on gathering comprehensive and representative input from patients is now available from the US Food and Drug Administration (FDA).   The document is the...

USA – FDA updates platform for off-label drug use

An online case reporting platform has been optimized for COVID-19 and will be the springboard for a new public-private drug repurposing collaboration.   The CURE ID online platform...

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