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Vaccine EUA Would Follow Efficacy: Marks
[2723 Words]
[ Price : $8.95]
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| CBER director Peter Marks tells an online health summit that a Covid vaccine EUA could be approved within weeks after a vaccine meets efficacy requirements. |
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07/30/2020
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FDA Draft Guide on Endotoxin Limits
[101 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” |
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07/29/2020
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Rule on Animal Drug e-Submission Safety Reports
[80 Words]
[ Price : $8.95]
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| Federal Register notice: FDA issues a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. |
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07/29/2020
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Guide on Multiple Function Device Products
[100 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a final guidance on “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.” |
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07/29/2020
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Unit-Dose Expiration Dating Guidance
[2661 Words]
[ Price : $8.95]
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| FDA issues a guidance explaining when the agency will not take action regarding requiring stability studies for repackaged products and expiration dates under those circumstances. |
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07/29/2020
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Pregnancy, Lactation, Reproduction Draft Guidance
[2747 Words]
[ Price : $8.95]
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| FDA issues a draft guidance to help applicants comply with content and format requirements for drug label subsections on pregnancy, lactation, and people of reproductive potential. |
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07/29/2020
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Breast Cancer Endpoint Guidance
[2768 Words]
[ Price : $8.95]
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| FDA issues a guidance on using pathological complete response as an endpoint for accelerated approval of drugs to treat high-risk early-stage breast cancer. |
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07/29/2020
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Pacira Paying $3.5 Million for FCA Kickback Charges
[2677 Words]
[ Price : $8.95]
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| The Justice Department says Pacira Pharmaceuticals is paying $3.5 million to resolve a whistleblower charge that it provided kickbacks to doctors to induce them to prescribe its Exparel analgesic. |
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07/29/2020
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CDER Updates Inactive Ingredient Database
[208 Words]
[ Price : $8.95]
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| FDA updates its inactive ingredient database to allow users to perform electronic queries to obtain accurate maximum daily exposure information for excipients for each route of administration. |
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07/29/2020
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