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FDA Warns McKesson on Opioid Tampering
[3030 Words]
[ Price : $8.95]
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| FDA commissioner Scott Gottlieb says that as part of agency efforts to combat the opioid crisis it has issued a Warning Letter to McKesson for supply chain violations involving opioids and other drugs. |
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02/12/2019
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Regulatory Science Centers Growing
[4953 Words]
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| FDA Critical Path and Regulatory Science Initiatives director Frank Weichold explains the Centers for Regulatory Science and Innovation program and the need for dedicated funding for the program’s research projects. |
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02/12/2019
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Draft Biosimilar Q&As Praised
[2775 Words]
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| Allergan applauds an FDA draft guidance with questions and answers on the biosimilar product development process. |
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02/12/2019
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4 Former FDAers Join Parexel
[2679 Words]
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| Four former FDA CDER and CBER executives join the Parexel regulatory consulting group. |
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02/12/2019
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FDA Releases Lupin Limited FDA-483
[2738 Words]
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| FDA releases an FDA-483 with six observations from an inspection at Indian drug company Lupin Limited. |
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02/12/2019
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WHO Alert for Fake Iclusig in Europe, Americas
[2661 Words]
[ Price : $8.95]
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| A World Health Organization product alert says falsified versions of Takeda/Incyte’s leukemia drug Iclusig are circulating in Europe and the Americas, including on the Internet. |
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02/12/2019
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FDA Appoints New Generic Drugs Director
[227 Words]
[ Price : $8.95]
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| FDA appoints CDER Office of Study Integrity and Surveillance deputy director Sally Choe as permanent director of the Office of Generic Drugs. |
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02/12/2019
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