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The US Food and Drug Administration (FDA) has issued draft guidance for industry on the development of drugs to treat neovascular or “wet” age-related...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 – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated...
The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said...
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Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...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The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
USA – Industry requests more information from FDA on dosage and administration labeling
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
USA – FDA considers new efficacy endpoint for diabetes drugs
The US Food and Drug Administration (FDA) on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new antidiabetic drugs and...
USA – FDA guidance focuses on Real-Time Oncology Review program
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
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