USA – FDA finalizes electronic postmarketing safety reporting guidance

The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically....

USA – FDA final guidance targets neonatal pharmacology studies

The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...

USA – FDA issues final guidance on AML drug development, two oncology draft guidances

The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of...

USA – Uptake of biosimilars on the rise in the US, but number of...

Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...

USA – FDA outlines criteria for conducting long-term neurodevelopmental safety studies in neonates

The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental...
New guidance on biologics affects authorized generics

USA – FDA outlines risk-based approach to monitoring clinical trials

The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring...

USA – FDA offers guidance on development of antimicrobials for diabetic foot infections

The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...

USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation

Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a...

USA – Industry experts tout potential for master protocols in pediatric clinical trials

Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...

USA – FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug...

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