February 6th, 2021
On February 2, 2021, Lassman Law+Policy submitted a Citizen Petition to the Food and Drug Administration (FDA) on behalf of Amneal Pharmaceuticals LLC. The petition asks FDA to refuse to approve proposed dosing modifications for vasopressin based on patient genotype because they appear to be unnecessary, without adequate scientific support, and potentially unsafe for patients treated for vasodilatory shock. FDA has 180 days to respond to the Citizen Petition.
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Scott Lassman
Scott Lassman has more than 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice. He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters...
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