USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
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 – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
Drugmakers laud the US Food and Drug Administration’s (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders,...
USA – FDA finalizes guidance on drug development for diabetic foot infections
The US Food and Drug Administration (FDA) finalized its advice to drugmakers developing treatments for diabetic foot infections without bone and joint involvement, focusing...
USA – FDA finalizes guidance giving ANDA facilities time to comply with cGMP
The US Food and Drug Administration (FDA) will give generic drug manufacturers more time to bring facilities not fully compliant with its current good...
USA – FDA issues draft guidances covering BIMO inspections
The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the...
USA – AAM seeks clarity, leeway in BA/BE studies guidance
The Association for Accessible Medicines (AAM) wants the US Food and Drug Administration (FDA) to clarify what its expectations of sponsors of bioavailability (BA)...
USA – Experts, FDA officials discuss future of clinical trials
Officials from the US Food and Drug Administration (FDA) and participants from the JAMA Summit on clinical trials recently highlighted the relationship between the...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
