Fwd: FDAAdvisoryCommittee.com Weekly Update - May 23, 2006

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"FDAAdvisoryCommittee.com" <fdaadvisorycommittee.com@...> wrote: Date: Tue, 23 May 2006 01:15:00 -0400 (EDT)From: "FDAAdvisoryCommittee.com"<fdaadvisorycommittee.com@...>redhead60707@...Subject: FDAAdvisoryCommittee.com Weekly Update - May 23, 2006FDA Advisory Committee - Email "The Pink Sheet" "The

Tan Sheet" Health News Daily NDA Pipeline Pharmaceutical Approvals Allergenic ProductsAnesthetic and Life Support DrugsAnti-Infective Drugs Pediatric SubcommitteeAntiviral Drugs Immunosuppressive DrugsArthritis DrugsBlood ProductsCardiovascular and Renal DrugsCellular, Tissue and Gene Therapies Biological Response ModifiersDermatologic and Ophthalmic DrugsDevice PanelsDrug Safety and Risk Mgmt Drug AbuseEndocrinologic and Metabolic DrugsGastrointestinal DrugsMedical Imaging DrugsNonprescription DrugsOncologic Drugs PediatricPediatric Ethics Subcmte.Peripheral and Central Nervous System DrugsPharmaceutical Science Nonclinical Studies Manufacturing Pharmacology/Toxicology Clinical Pharmacology Orally Inhaled & Nasal Drug ProductsPharmacy CompoundingPsychopharmacologic DrugsPublic MeetingsPulmonary-Allergy DrugsReproductive Health DrugsScience BoardTransmissible Spongiform EncephalopathiesVaccines and Related Biological Products

A D V E R T I S E M E N T Gardasil Efficacy In Patients Already Infected With HPV Will Be Addressed By Vaccines Cmte.[Committee Meeting on May 18, 2006]FDAAdvisoryCommittee.com will not be webcasting this event – DVDs/Videotapes will be available upon request. FULL STORY>>Exelon Panel To Debate Parkinson's-Related Dementia As Distinct Condition[Committee Meeting on May 17, 2006]The Peripheral & Central Nervous System Drugs Advisory Committee’s review of Novartis’ Exelon will center on whether dementia

associated with Parkinson’s disease warrants a separate indication from Alzheimer’s-related dementia. FULL STORY>>Webcast Available - Bristol Sprycel For Gleevec-Resistant Leukemia To Get Cmte.

Review At June ASCO Meeting[Committee Meeting on June 2, 2006]FDA will take its Oncologic Drugs Advisory Committee on the road to review Bristol-Myers Squibb’s Sprycel (dasatinib) for the treatment of resistant leukemias. FULL STORY>>Medical Devices Advisory Cmte. To Meet May 23[Committee Meeting on May 23, 2006]FDA’s Radiological Devices Panel of the Medical Devices Advisory Committee will meet on May 23 to make recommendations on the reclassification of full field digital mammography systems from Class III to Class II devices, following an FDA presentation. FULL

STORY>>Cephalon Sparlon Additional Pre-Approval Safety Study Recommended To Assess Skin Reaction Risk[Committee Meeting on March 23, 2006]Cephalon should conduct a 3,000-patient safety study of Sparlon in children with attention deficit/hyperactivity disorder to rule out a higher risk of serious skin reactions, FDA’s Psychopharmacologic Drugs Advisory Committee concluded at its March 23 meeting. FULL STORY>> Merck Gardasil Slated For Advisory Committee Review May 18 [Posted: 5/3/06]Antihypertensive Class Labeling Public Health Impact Assessment Being Considered By FDA [Posted: 4/25/06]Ovarian Cancer Clinical Endpoints Will Be Topic Of FDA/ASCO Public Workshop [Posted: 3/14/06]Novartis' Exelon To Be Reviewed By Advisory Cmte. May 17 [Posted: 2/27/06]Cellegy Headache: FDA Says Analgesic Use May Have Skewed Cellegesic Efficacy Results [Posted: 4/24/06]Cellegy Cellegesic Re-Analysis Of Anal Fissure Pain Relief Data Slated For Committee Review [Posted: 2/22/06]FDA Antihypertensive Draft Class Labeling To Be Reviewed By Cardio-Renal Committee [Posted: 2/22/06]ADHD Black Box Warning On Psychiatric/Cardiac Events Is Unnecessary, Pediatric Committee

Says [Posted: 3/23/06]FDA Science Board To Continue Drug Safety

Focus [Posted: 3/10/06] FDA Panel To Decide If Adept Adhesion Prevention Device Is True To Its Name MORE>> Click HERE to remove your name from this email list. Live Webcasts couple moment-to-moment coverage with essential committee news and information. View a sample Buy a webcast, videoconference or videotape A D V E R T I S E M E N T Copyright and Privacy Policy

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