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Multiple CGMP Violations at Colorful Products
[2859 Words]
[ Price : $8.95]
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| FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug products and hand sanitizers. |
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05/17/2022
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API Deviations at Specialty Process Labs
[2871 Words]
[ Price : $8.95]
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| FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients. |
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05/17/2022
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FDA Accepts scPharmaceuticals NDA for Furoscix
[127 Words]
[ Price : $8.95]
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| FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients with worsening heart failure. |
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05/17/2022
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Guide on Container Labeling Safety Considerations
[122 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” |
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05/17/2022
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Consultants Submit Draft AAV Guidance to FDA
[2703 Words]
[ Price : $8.95]
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| Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultation with other experts. |
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05/17/2022
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Improving Trial Representation Book
[2814 Words]
[ Price : $8.95]
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| The National Academies produces a book on improving representation for women and minorities in clinical trials and research. |
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05/17/2022
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Apollo Care FDA-483
[2692 Words]
[ Price : $8.95]
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| FDA releases the FDA-483 with five observations from an inspection at the Columbia, MO-based Apollo Care outsourcing facility. |
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05/17/2022
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Guide on Generic User Fee Assessments
[84 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a final guidance entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” |
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05/17/2022
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Senate Bill to Restore FDA Orphan Drug Interpretation
[216 Words]
[ Price : $8.95]
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| Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA interprets orphan drug exclusivity. |
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05/17/2022
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