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Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. Read More
The FDA is asking clinical investigators who sponsor trials to submit many of the elements that a commercial sponsor would include in an investigational new drug application. Read More
The ayes had it with the House Energy & Commerce Committee May 21, with all 51 members voting to pass the latest version of the 21st Century Cures Act. Read More
A year after a consortium of stakeholders issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA yesterday issued draft guidance giving drugmakers more leeway in how those drugs are created. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
A federal appeals court is considering whether to lift a temporary injunction that bars Sandoz from marketing its Zarxio-sndz biosimilar pending an outcome in patent infringement litigation involving reference product maker Amgen’s blockbuster chemotherapy drug Neupogen. Read More
Genzyme said Thursday that it has received FDA breakthrough therapy designation for olipudase alfa, an enzyme replacement therapy for patients with nonneurological manifestations of acid sphingomyelinase deficiency, also known as Niemann-Pick disease type B. Read More