USA – FDA expands types of acceptable confirmatory evidence in new guidance

In a new draft guidance, the US Food and Drug Administration (FDA) outlined the types of confirmatory evidence it will accept from sponsors that...

USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels

In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug...

The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products. When...

USA – FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against...

Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently...

USA – FDA finalizes guidance on use of human factors studies in combination product...

The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the...

USA – FDA draft guidance focuses on postapproval trial diversity data

Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs...

USA – FDA finalizes guidance on standards for tracing products through supply chain

The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email...

USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III

The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...

USA – FDA finalizes guidance on real-world evidence in drug approvals

The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in...

USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy

Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about...

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