FDA

The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) announced a study of oncology…

The US Food and Drug Administration (“FDA”) provided a report to Congress, entitled Pediatric Labeling of Orphan Drugs, detailing…

The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) sent a Warning Letter to Galt…

The US Food and Drug Administration (“FDA”) released quarterly data on two programs intended to increase generic competition and…

The FDA’s regulation of medicinal cannabidiol containing products is an ongoing work in progress. However, the FDA’s recent spate…

The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation…

In May, the US Food and Drug Administration (“FDA”) released a draft guidance outlining its current thinking on real-world data…

The US Food and Drug Administration (“FDA”) issued two new draft guidances relating to the labeling requirements for human…

The US Food and Drug Administration (“FDA”) recently published its quarterly Real Time Report on new drug application (“NDA”) and…

Last month, a federal judge in Boston overturned the convictions of two former employees of New England Compounding Center…