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FDA releases PDUFA goals

DIA Global SmartBrief | Jul 19, 2016

The FDA published a 46-page document detailing the performance and procedural goals for fiscal 2018 to 2022 as part of the sixth iteration of the Prescription Drug User Fee Act. The document presents the agency's plan on user fees, lists deadlines for pilot projects and guidance documents, and notes important themes such as biomarker qualification, increased pharmacovigilance, patient input on the regulatory process and the use of real-world evidence. Regulatory Focus (07/15)


How Big Pharma escaped ACA regulation

DIA Global SmartBrief | Jul 21, 2016

FDA bans API imports from Chinese, Indian companies

DIA Global SmartBrief | Jul 21, 2016

Draft guidance issued by FDA on developing companion IVD, therapeutics

DIA Global SmartBrief | Jul 19, 2016

Researchers see AIDS cure as difficult but achievable

DIA Global SmartBrief | Jul 19, 2016

India holds line on drug prices

DIA Global SmartBrief | Jul 21, 2016

Explore the June Global Forum

DIA Global SmartBrief | Jul 19, 2016

Smaller immunotherapy companies are in demand

DIA Global SmartBrief | Jul 21, 2016

New R&D, training center opened by Boston Scientific in India

DIA Global SmartBrief | Jul 19, 2016

African Union approves creation of pan-African Disease Control center

DIA Global SmartBrief | Jul 21, 2016


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DIA Global SmartBrief | Jul 14, 2016

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