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12 Observations in Celltrion FDA-483
[2832 Words]
[ Price : $8.95]
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| FDA releases the FDA-483 detailing 12 observations from a 2017 inspection at Korea’s Celltrion drug manufacturing facility. |
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04/13/2018
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Final Guidance on Special Protocol Assessments
[240 Words]
[ Price : $8.95]
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| FDA posts a guidance on Special Protocol Assessment that provides drug manufacturers with information about the procedures and policies adopted by CDER/CBER for reaching an agreement on the design and size of certain clinical trials that could support marketing approval. |
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04/13/2018
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Panel to Review Siga Tech Smallpox NDA
[89 Words]
[ Price : $8.95]
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| Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat. |
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04/13/2018
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Info Collection Extension on Dispute Resolution
[103 Words]
[ Price : $8.95]
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| Federal Register notice: FDA submits for OMB approval an information collection extension for its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” |
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04/13/2018
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Guide on Ultrasonic Diathermy Device 510(k)s
[148 Words]
[ Price : $8.95]
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| FDA releases a final guidance on “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.” |
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04/13/2018
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NJ Court Hands Down $33 Million Verdict Against Bard
[156 Words]
[ Price : $8.95]
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| A state court jury in New Jersey hands down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective pelvic mesh implants. |
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04/13/2018
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Info Collection Extension for Accredited Persons Inspections
[93 Words]
[ Price : $8.95]
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| Federal Register notice: FDA submits to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program.” |
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04/13/2018
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Alert on Recalled Coastal Meds Sterile Drugs
[104 Words]
[ Price : $8.95]
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| FDA alerts health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some drug vials for injection. |
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04/13/2018
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ICH Addendum to Pediatric Trial Guide
[113 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” |
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04/12/2018
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