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The World Health Organization is seeking public comment on its first attempt to create international shelf life policies for medical products. Read More
European drugmakers will be allowed to make generics and biosimilars after the European Parliament on Wednesday voted in favor of manufacturing waivers that will allow their export. Read More
Health Canada released two draft guidances to clarify proposed changes to the agency’s abbreviated new drug submission (ANDS) pathway for generics. Read More
CBER Director Peter Marks highlighted two gene therapy approvals in a report on the center’s achievements for fiscal 2018, released on Wednesday. Read More
In an open letter on Wednesday to his Republican counterpart on the House Committee on Oversight and Reform, Chairman Elijah Cummings (D-Md.) said he will give drugmakers the committee’s protocol for guarding their potentially sensitive internal documents. Read More