USA – FDA adds breakpoint updates to antimicrobial susceptibility test system device labeling guidance
The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates...
USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for...
USA – FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
USA – FDA guidance on conducting trials during emergencies shifts away from COVID-19
The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters...
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In a new draft guidance, the US Food and Drug Administration (FDA) outlined the types of confirmatory evidence it will accept from sponsors that...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In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...
USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug...
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products.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USA – FDA draft guidance focuses on postapproval trial diversity data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...
