'Fda review' presentation slideshows

1.87k views • 88 slides

BIOL 62 Antibiotic Resistance Consequences & Mechanisms

868 views • 66 slides

Assessment of the cardiovascular risks and health benefits of rosiglitazone

Assessment of the cardiovascular risks and health benefits of rosiglitazone. David J. Graham, MD, MPH Office of Surveillance and Epidemiology Food and Drug Administration July 30, 2007. The questions of greatest importance to OSE.

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The Name Game : How the USPTO and Changing FDA Approval Processes Affect Protection of New Drug Names

The Name Game : How the USPTO and Changing FDA Approval Processes Affect Protection of New Drug Names. Lisa M. Tittemore, Esq. Keith E. Toms, Esq. Bromberg & Sunstein LLP November 5, 2008. Presentation Overview.

589 views • 34 slides

The Name Game The USPTO and FDA Approval Process Selection and Protection of New Drug Names

The Name Game The USPTO and FDA Approval Process Selection and Protection of New Drug Names. Lisa M. Tittemore, Esq. Presentation Overview. U.S. Patent & Trademark Office (USPTO) procedures and issues relevant to prosecution of drug name trademarks

567 views • 34 slides

Monoclonal antibody therapeutics SLA Pharmaceutical & Health Tech. Division April 2008

Monoclonal antibody therapeutics SLA Pharmaceutical & Health Tech. Division April 2008. Janice Reichert, Ph.D. Senior Research Fellow Tufts CSDD, Tufts University. Topics. Brief overview of industry and benchmarking Monoclonal antibody therapeutics Structure and function

522 views • 33 slides

FDA Legal & Regulatory Considerations for Biomedical Startups

FDA Legal & Regulatory Considerations for Biomedical Startups. Tech Coast Angels San Diego, California March 7, 2003. FDA Counsel .com. Michael A. Swit, Esq. Michael A. Swit, Esq. Law Offices of Michael A. Swit 539 Samuel Ct. Encinitas, CA 92024 760-815-4762; fax: 760-454-2979

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ASENT 13 th Annual Meeting Outcome Measures to Support Labeling Claims: What is new FDA Guidance?

ASENT 13 th Annual Meeting Outcome Measures to Support Labeling Claims: What is new FDA Guidance?. Elektra J. Papadopoulos, M.D., M.P.H. Study Endpoints and Labeling Development CDER/FDA February 24, 2011. Disclosures. No conflicts. Presentation Outline. FDA review of rating scales

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The FDA Review Process

The FDA Review Process. Dan Takefman, PhD Chief, Gene Therapy Branch DCGT/OCTGT/CBER/FDA IOM Meeting 6/4/13. Overview. IND Review Process Regulatory framework Discipline review focus FDA and RAC Respective roles How we interact. 2. Basis for Review Decisions.

530 views • 23 slides

The FDA Review Process

The FDA Review Process. Dan Takefman, PhD Chief, Gene Therapy Branch DCGT/OCTGT/CBER/FDA IOM Meeting 6/4/13. Overview. IND Review Process Regulatory framework Discipline review focus FDA and RAC Respective roles How we interact. 2. Basis for Review Decisions.

745 views • 23 slides

Louis B. Jacques, MD Director Coverage & Analysis Group

WSMOS 2012. Louis B. Jacques, MD Director Coverage & Analysis Group. Topics. Coverage Process FDA and CMS MOU Parallel Review Targeted Therapies and Molecular Diagnostics MolDx. Social Security Act 1862(a)(1).

245 views • 22 slides

NDA 20-449 SE-011 Docetaxel

NDA 20-449 SE-011 Docetaxel. FDA Review. Biostatistics Clara Chu, PhD. Gang Chen, PhD. Biopharmaceutics Safaa Ibrahim PhD Atiq Rahman, PhD. Project Manager Ann Staten, RD Medical Julie Beitz, MD. FDA Review Team. Proposed Indication.

351 views • 15 slides

FDA, PDUFA AND MEDICAL INNOVATION Spring 2012

FDA, PDUFA AND MEDICAL INNOVATION Spring 2012. What is the Food and Drug Administration (FDA)?. The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting the public health by:.

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510(k)s

510(k)s. Percent of 510(k)s With Additional Information (AI) Request on 1 st FDA Review Cycle. Average Time to Decision: 510(k)s* (Receipt Cohorts as of June 30, 2012). *SE and NSE decisions only; times may not add to total due to rounding

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West Nile Virus and Plasma-Derived Products FDA Blood Product Advisory Committee Meeting 18 September 2003

West Nile Virus and Plasma-Derived Products FDA Blood Product Advisory Committee Meeting 18 September 2003. Mahmood Farshid, Ph.D. Division of Hematology OBRR, CBER. Current Review Approach for Viral Clearance Studies in Human Blood Derived Products.

293 views • 11 slides