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About Alice Read the Report Select County by NameAdamsAllenAshlandAshtabulaAthensAuglaizeBelmontBrownButlerCarrollChampaignClarkClermontClintonColumbianaCoshoctonCrawfordCuyahogaDarkeDefianceDelawareErieFairfieldFayetteFranklinFultonGalliaGeaugaGreeneGuernseyHamiltonHancockHardinHarrisonHenryHighlandHockingHolmesHuronJacksonJeffersonKnoxLakeLawrenceLickingLoganLorainLucasMadisonMahoningMarionMedinaMeigsMercerMiamiMonroeMontgomeryMorganMorrowMuskingumNobleOttawaPauldingPerryPickawayPikePortagePreblePutnamRichlandRossSanduskySciotoSenecaShelbyStarkSummitTrumbullTuscarawasUnionVan WertVintonWarrenWashingtonWayneWilliamsWoodWyandot Use the interactive map to the left to select a county to view our ALICE data or use the drop down menu above to select a county by name Use the drop down menu above to select a county by name to view our ALICE …

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Medical Device User Fee IV (MDUFA IV)

October 3, 2017 Drug & Device Advisory Group FDA Briefs Medical Device User Fee IV (MDUFA IV) Medical Device User Fee IV (MDUFA IV) August 18, 2017 : President signed FDA Reauthorization Act of 2017 (FDARA), which includes the reauthorization of MDUFA Background of User Fee Legislation User Fees Performance Goals Program Highlights LEARN Image credit: FDA …

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#FDA Sunday TWEETORIALS

June 18, 2018 Drug & Device Advisory Group Link and Learn #FDA Sunday TWEETORIALS Sunday TWEETORIALS from FDA Commissioner LEARN Image credit: Twitter Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory Group View all posts by Drug & Device Advisory Group Leave a Reply Cancel reply Enter your …

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FDA Drug Approvals: IMFINZI, ALUNBRIG – Drug and Device Digest

FDA BRIEF: Week of May 8, 2017 IMFINZI (durvalumab) injection AstraZeneca. Wilmington, DE, USA VENTANA PD-L1 (SP263) Assay Ventana Medical Systems, Inc., Tucson, AZ, USA INDICATION: Treatment of patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy have disease progression within 12 months of neoadjuvant or adjuvant …

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Increased availability of NIOSH approved respirators to healthcare personnel

March 3, 2020 Drug & Device Advisory Group Link and Learn Increased availability of NIOSH approved respirators to healthcare personnel FDA and CDC take action to increase access to respirators, including N95s, for health care personnel FDA-CDC collaboration to prioritize access to needed medical products through Emergency Use Authorization (EUA)  Certain industrial respirators during the …

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FDA Databases for Post-Approval Requirements

February 15, 2016 Drug & Device Advisory Group Link and Learn FDA Databases for Post-Approval Requirements   WHAT: Database for  oversight and tracking Studies, Requirements and Commitments postapproval. WHY: Need for oversight. Drug studies, mandated as condition of approval (accelerated approval) or for improving prescribing and use, quality and consistency. Device studies mandated as condition …

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Drug and Device Approvals: YESCARTA, IMPELLA RP – Drug and Device Digest

Week of October 16, 2017 YESCARTA™ (axicabtagene ciloleucel) suspension for intravenous infusion Kite Pharma, Inc. (Gilead company) INDICATION: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising …

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Drug and Device Development – Drug and Device Digest

Drug and Device Development Clinical Pharmacology Cards: JADENU, SYNJARDY September 13, 2016September 13, 2016 skg2787Leave a comment CLINICAL PHARMACOLOGY CARDS     Mechanism of Action   Orally active chelator that is selective for iron (as Fe3+) for the treatment of chronic iron overload due to blood transfusions. Pharmacodynamics (PD)         Deferasirox (10, 20,and …

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FDA News: AAMI Technical Information Report, Fraudulent Cancer Products

May 1, 2017 Drug & Device Advisory Group FDA Briefs FDA News: AAMI Technical Information Report, Fraudulent Cancer Products FDA BRIEF: Week of April 24, 2017 AAMI Technical Information Report on “Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.” FDA + Association for the Advancement of Medical Instrumentation (AAMI) report Applies to medical …

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