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Drug Compounding Information Collection Revision
[79 Words]
[ Price : $8.95]
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| Federal Register notice: FDA seeks comments on an information collection revision entitled “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.” |
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06/17/2022
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Info Collection on Influenza A Reagents Guide
[139 Words]
[ Price : $8.95]
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| Federal Register notice: FDA sends to OMB an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866.” |
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06/17/2022
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Bill Would Establish FDA/USPTO Patent Task Force
[263 Words]
[ Price : $8.95]
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| Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) introduce bipartisan legislation that would establish a task force between the U.S. Patent and Trademark Office and FDA to improve communication and coordination in implementing each agency’s activities related to patents. |
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06/17/2022
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Guide on Quantitative Imaging Device Filings
[76 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a final guidance entitled “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.” |
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06/16/2022
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Central Admixture Pharmacy FDA-483
[197 Words]
[ Price : $8.95]
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| FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services. |
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06/16/2022
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Merck Keytruda sBLA for Non-small Cell Lung Cancer
[181 Words]
[ Price : $8.95]
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| FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II or IIIA non-small cell lung cancer following complete surgical resection. |
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06/16/2022
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