Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
USA – Researchers suggest FDA needs authority to require pediatric studies for orphan drugs
The US Food and Drug Administration (FDA) may need greater authority to require pediatric clinical studies for drugs, including orphan drugs, according to a...
USA – FDA finalizes BIMO electronic submission guidance
The US Food and Drug Administration (FDA) has finalized guidance for sponsors on electronically submitting data on drugs and biologics that the agency will...
USA – Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering...
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The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug...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....
