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FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World Economic Forum in Davos, Switzerland. Read More
The stay will be either until March 30, until the guidance’s early publication, or an announcement that the guidance will be published after March. Read More
The investigator also noted inconsistent and unreliable manufacturing processes that likely resulted in batches of inconsistent quality, purity and strength. Read More
The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility. Read More
The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination. Read More
The FDA hit Australian drugmaker Delta Laboratories with a warning letter for significant violations, including unreliable manufacturing processes, flawed stability testing and a lack of stability data. Read More
The FDA filed a joint motion with Endo to pause the company’s lawsuit accusing the agency of breaking the law with its decree authorizing bulk compounding of drugs. Read More
Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More