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 – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
USA – HHS issues guidance on legally prescribed drugs for abortion
The Biden administration on Wednesday said retail pharmacies and pharmacists must provide patients with the medication they were legally prescribed even if it could...
USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA...
The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User...
USA – FDA releases guidance on compounding beta-lactam products in shortage
The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam...
USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – European, US guidance differs on API nitrosamines
HARDLY A DAY goes by without mention of a newly emerging active pharmaceutical ingredient (API) nitrosamine, eg, nitrosamine propranolol.1 This has led to a great...
USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs
The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII)...
