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- Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminantsPar Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
- FDA releases draft guidance on evaluating drug behavior in patients with liver impairmentThe FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…raps · 1mo agoRegulatoryNeutral