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The FDA is not ruling out further use of remote assessments for Good Clinical Practice (GCP) inspections postpandemic, but the agency is clear: the bulk of its inspection activity will remain onsite despite more remote-based approaches catching on elsewhere. Read More
The Senate is expected to vote today to end discussion on a continuing resolution that would keep the federal government funded at fiscal 2021 levels beyond Feb. 18. Read More
The FDA approved the 100th abbreviated new drug application (ANDAs) through its congressionally established Competitive Generic Therapy (CGT) pathway in 2021, bringing new low-priced medicines to the market for originator drugs that the agency had deemed to have inadequate generic competition. Read More
Sage Therapeutics’ investigational antidepressant, zuranolone, posted positive topline results this week in a phase 3 trial showcasing its potential as an add-on therapy co-administered with a range of standard-of-care antidepressants. Read More
The FDA has issued a warning letter to Indiana Chem-Port, an active pharmaceutical ingredient (API) manufacturer in Gujarat, India, for significant deviations from current good manufacturing (GMP) practices, rendering its products adulterated. Read More
EMA follows FDA, which in December added its strictest warnings to the labels of a handful of JAK inhibitors, citing risk of serious health issues and death. Read More
HSS recently appealed court rulings that said the agency shouldn’t have slapped the drugmakers with fines for refusing to participate in the program. Read More
Six Republican senators including Mike Lee (Utah), Ted Cruz (Tex.) and Rand Paul (Ky.) circulated a “Dear Colleague” letter on Tuesday to other lawmakers, signaling their intention to delay voting on the continuing resolution to fund the government beyond Feb. 18 unless it includes an amendment to defund federal COVID-19 vaccine mandates. Read More