February 10, 2010 - Oncologic Drugs Advisory Committee - http://FDAAC.com

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February 10, 2010 - Oncologic Drugs Advisory Committee

NDA - PIXUVRI (Cell Therapeutics)

NDA - OMAPRO (ChemGenex Pharm)

Agenda: On February 10, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.

During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib.

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REMINDER: FDA Social Media Webcast on November 12 & 13

November 12 & 13, 2009

Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools

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FDAAdvisoryCommittee.com

Agenda: The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the promotion of FDAregulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.
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Vaccines and Related Biological Products Advisory Committee - FDAAC.com

November 18, & 19, 2009

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BLA 125324 - H1N1 Discussion
BLA 125285 - Influenza Vaccine

Nov. 18th Agenda: The committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate vaccine (Diphtheria CRM197 Protein),BLA 125324, and will hear an update on FDA’s Influenza A (H1N1) 2009 monovalent vaccine activities; Postmarketing surveillance.

Nov. 19th Agenda: The committee will discuss and make recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN 125285.


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Pulmonary-Allergy Drugs AdComm - FDAAC.com

November 18, 19 & 20, 2009

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Nov. 18th Agenda: The committee will discuss new drug application (NDA) 22-368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.

Nov. 19th Agenda: The committee will discuss the efficacy supplement for new drug application (sNDA) 21-395, for the approved product Spiriva HandiHaler (tiotropium inhalation powder), manufactured by Boehringer Ingelheim, for the reduction in exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).

Nov. 20th Agenda: The committee will discuss new drug application (NDA) 22-368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.

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FDA Social Media Webcast on November 12 & 13

November 12 & 13, 2009

Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools

To sign up for the live webcast, go to http://fdaac.com
FDAAdvisoryCommittee.com

Agenda: The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the promotion of FDAregulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.
To sign up for the live webcast, go to http://fdaac.com