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FDA Cites Chinese Contract Research Laboratory for GLP Deficiencies
FDA investigators cited JOINN Laboratories (Suzhou) Co., a Chinese nonclinical testing laboratory, for deficiencies involving specimen tracking, laboratory procedures and animal housing facilities during a 5/11-15 inspection. The agency issued a two-observation Form 483 to the laboratory, located in Taicang, Jiangsu Province, identifying problems with compliance with
FDA OKs Imfinzi + Padcev for Bladder Cancer
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Pfizer and Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy (RC), for treating adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for or who
Former CDC Director Urges Swift Overton Confirmation
Former CDC Director Robert Redfield is urging the Senate to confirm Heidi Overton as FDA commissioner before the end of the year, arguing that prolonged uncertainty over the agency's leadership could undermine U.S. competitiveness in biotechnology and threaten national health security. In a recent opinion article, Redfield
The Impacts of Dose Interruptions on Cancer Drug Efficacy: FDA
Interrupting treatment with certain lung cancer drugs may have a greater adverse effect on efficacy than reducing their dosage, according to a new analysis by FDA researchers published in Clinical Cancer Research. The researchers examined patient-level data from clinical trials supporting the original FDA approvals of four epidermal growth