Simplifying Global Compliance
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April 18, 2019
Vol. 18
No. 75
Headlines
Editor’s Note
In observance of spring holidays, Drug Industry Daily will not be published Friday, April 19. The next issue will be published Monday, April 22. Read More
Full Issue of Drug Industry Daily
View the entire issue. Read More
Cummings Presses Ahead on Drug Pricing Investigation
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
European Parliament Evens Scales for Generics Makers With New SPC Waivers
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
CBER Touts Gene Therapy, Vaccine Approvals in FY2018
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
Canada Issues Guidance on Abbreviated New Drug Submissions
Health Canada released two draft guidances to clarify proposed changes to the agency’s abbreviated new drug submission (ANDS) pathway for generics. Read More
