USA – FDA asks manufacturers to develop risk management plans to avert shortages
The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical...
USA – FDA’s drug approvals in 2022
Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. This is a drop from the highs of the...
USA – FDA issues guidance on drug development for neovascular age-related AMD
The US Food and Drug Administration (FDA) has issued draft guidance for industry on the development of drugs to treat neovascular or “wet” age-related...
USA – MedCon: TAP pilot off the ground four devices enrolled
The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while...
USA – Draft guidance outlines FDA’s testing requirements for tissue containment systems
A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power...
USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...
USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
USA – FDA details approach for finding optimal dosages for new cancer drugs
The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
