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Indivior Exec Pleads Guilty in Suboxone Film Case
[2632 Words]
[ Price : $8.95]
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| The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of introducing misbranded Subxone Film into interstate commerce. |
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09/01/2020
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Nitrosamine Control Guidance Out
[2705 Words]
[ Price : $8.95]
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| FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs. |
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09/01/2020
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Hahn Should Tell Truth or Resign: Topol
[466 Words]
[ Price : $8.95]
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| Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to hold a press conference and tell the truth about how he was pressured to misrepresent the effectiveness of convalescent plasma or resign. |
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09/01/2020
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Don’t Let Orange Book Block Competition: 23 AGs
[2671 Words]
[ Price : $8.95]
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| Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book as a way to speed generic competition. |
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09/01/2020
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Regulatory Review Period for Lumoxiti
[108 Words]
[ Price : $8.95]
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| Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharma’s Lumoxiti. |
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09/01/2020
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Info Collection on Biologic Adverse Experience Reporting
[92 Words]
[ Price : $8.95]
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| Federal Register notice: FDA seeks comments on an information collection extension for “Adverse Experience Reporting For Licensed Biological Products; and General Records—21 CFR Part 600.” |
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09/01/2020
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Guide on Device Patient-reported Outcomes Usage
[113 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. |
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08/31/2020
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FDA Releases Draft Bioequivalence ANDA Guides
[54 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. |
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08/31/2020
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FDA Approves Innocoll NDA for Xaracoll
[198 Words]
[ Price : $8.95]
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| FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. |
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08/31/2020
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