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Interstitial Cystitis Drug Effectiveness Guidance
[2644 Words]
[ Price : $8.95]
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| FDA publishes a draft guidance with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome. |
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12/04/2019
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Pilot Considered on Evaluating Novel Excipients
[220 Words]
[ Price : $8.95]
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| Federal Register notice: FDA establishes a docket to obtain information and comments that will assist it in determining whether to establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. |
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12/04/2019
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CDRH Industry Basics Webcast
[2652 Words]
[ Price : $8.95]
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| A CDRH Industry Basics webcast gives basic program information on the 513(g) device determination and classification process and the custom device exemption process. |
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12/04/2019
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Reg Review Period for Spark’s Luxturna
[97 Words]
[ Price : $8.95]
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| Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Spark Therapeutics’ Luxturna. |
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12/04/2019
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FDA Should Consider Free Speech Decisions: MIWG
[2774 Words]
[ Price : $8.95]
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| The Medical Information Working Group says FDA should incorporate principles from five recent Supreme Court free speech decisions into its consideration of manufacturer communications about unapproved uses of approved or cleared medical products. |
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12/04/2019
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Oncology Panel Review AstraZeneca, Merck
[144 Words]
[ Price : $8.95]
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| Federal Register notice: FDA announces a 12/17 Oncologic Drugs Advisory Committee meeting that with discuss an AstraZeneca supplemental NDA for Lynparza (olaparib) tablets, and a Merck supplemental BLA for Keytruda (pembrolizumab). |
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12/04/2019
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Rising Pharma Paying Over $3 Million in Price Fixing Charge
[2762 Words]
[ Price : $8.95]
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| The Justice Department says Rising Pharmaceuticals will pay over $3 million to resolve price fixing charges and will cooperate with an ongoing investigation into generic drug company alleged price fixing. |
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12/04/2019
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Tecentriq/Chemo Combo OK’d for Lung Cancer
[269 Words]
[ Price : $8.95]
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| FDA approves a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of certain adults with metastatic non-squamous non-small cell lung cancer. |
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12/04/2019
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