USA – FDA recommends collecting ovarian toxicity data in cancer drug trials
The US Food and Drug Administration (FDA) is proposing sponsors collect ovarian toxicity data during cancer drug development. The agency said that cancer drugs...
USA – FDA proposes removing oral phenylephrine from use in nasal decongestants
The US Food and Drug Administration (FDA) announced on Thursday plans to remove oral phenylephrine from the over-the-counter (OTC) monograph for nasal decongestants following...
USA – FDA revises more than 800 PSGs in line with ICH M13A
The US Food and Drug Administration (FDA) on Thursday published revised draft product-specific guidances (PSGs) for immediate-release solid oral generic drugs deemed to be...
USA – FDA drafts guidance on drug interaction labeling
The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug...
USA – Guidance : Core Patient-Reported Outcomes in Cancer Clinical Trials
This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for...
USA – FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults....
USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance that’s intended to pave the way for using data from research...
USA – FDA’s final guidance on DCTs adds clarity on HCP task log, inspection...
The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by...
USA – Studies find uneven uptake of biosimilars as availability increases
As biosimilars become increasingly available, they are creating a competitive market with originator products, but uptake of biosimilars among patients is varied and depends...
USA – FDA drafts guidance on multiregional clinical trials in oncology
In a new draft guidance, the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to...
