USA – FDA finalizes guidance on adjusting for covariates in randomized trials
The US Food and Drug Administration (FDA) on Friday released a final guidance addressing how sponsors can adjust for covariates in analyzing randomized clinical...
USA – FDA proposes long-awaited patient medication information rule
The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while...
USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies
The US Food and Drug Administration (FDA) on Tuesday issued final guidance on the use of whole slide imaging in nonclinical toxicology studies. The...
USA – FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance offering examples of how drug sponsors can rely on generally accepted scientific...
USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
USA – Dual draft guidances outline FDA vision for pediatric drug development, exclusivity
In a move that could ruffle the feathers of pharmaceutical companies, the US Food and Drug Administration (FDA) says it aims to be more...
USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
