'Substantial evidence' presentation slideshows

Safety and Efficacy Evaluation of Preventive Vaccines

Safety and Efficacy Evaluation of Preventive Vaccines. Cynthia Kleppinger, M.D. Center for Biologics Evaluation and Research Food and Drug Administration December 7, 2000. Preventive Vaccines.

1.13k views • 74 slides

Safety Assessment of Food Additives

How FDA Regulates Food Additives? Safety Assessment of Food Additives Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Advisory Committee Additives and Ingredients Subcommittee LATEX ALLERGY

1.87k views • 72 slides

Patent Defenses and Remedies

851 views • 68 slides

What gives fireworks their different colors?

1.02k views • 65 slides

Breastfeeding & Medication

Breastfeeding & Medication. Breastfeeding & Medication. The benefits of breastfeeding are sufficiently important to recommend that breastfeeding should be discouraged only when there is substantial evidence that : - The drug taken by the mother will be

1.28k views • 52 slides

Non-APA Matters

Non-APA Matters. Applies to 1) , policy statements, 2) interpretative rules, 3) procedural, and 4) where there is a finding of good cause. If no notice is required, then neither will there be comment.

623 views • 46 slides

567 views • 36 slides

749 views • 35 slides

Ivette Cejas, PhD & CDaCI Investigative Team

571 views • 34 slides

Zometa for Prostate Cancer Bone Metastases

Zometa for Prostate Cancer Bone Metastases. Protocol 039 Amna Ibrahim, M.D. Oncology Drug Products FDA. Critical Questions: Study 039. Considering both the 4 mg and 8/4 mg arms, how convincing is the Prostate Cancer Trial (039)? Can data from other studies provide support?.

584 views • 29 slides

Promoting Collaborations Across Studies for Replication and Follow-up Studies

Promoting Collaborations Across Studies for Replication and Follow-up Studies. Robert N. Hoover, M.D., Sc.D Director Epidemiology and Biostatistics Program June 22, 2007. Outline. MEETING THE REQUIREMENTS FOR GOOD SCIENCE Extent of Collaboration Leadership Roles Resource Enhancement

412 views • 25 slides

Overview of the Uniform Child Custody Jurisdiction and Enforcement ACT and THE Hague Convention

Overview of the Uniform Child Custody Jurisdiction and Enforcement ACT and THE Hague Convention. Tracy Mills Guardian ad Litem. History. Predecessor to UCCJEA had been enacted by all 50 states by 1981 revised statute. UCCJEA passed in Utah in 2000.

539 views • 23 slides

Clinical Development Programs for Chronic Idiopathic Urticaria Indication for H1-antihistamines

Clinical Development Programs for Chronic Idiopathic Urticaria Indication for H1-antihistamines. Badrul A. Chowdhury, MD, PhD Medical Team Leader, Division of Pulmonary and Allergy Drug Products, CDER, US FDA. Outline.

575 views • 23 slides

CEQA Case Law

CEQA AND HISTORIC PRESERVATION. CEQA Case Law. March 19, 2014: 11:00 am to 11:45 am California Preservation Foundation University of Southern California. Deborah M. Rosenthal, AICP, Esq. Sheppard Mullin Richter & Hampton, LLP. #418641500. What is a Project?.

385 views • 19 slides

TOP - Hungary Guiding principles for road infrastructure safety investment projects

TOP - Hungary Guiding principles for road infrastructure safety investment projects. 7 February 2011 Budapest. Kristian DUUS JASPERS Regional Office for Central Europe, Vienna. Rationale. Road projects with documented safety impacts are supported by the Commission - ref EU targets

268 views • 15 slides

SJ MOTIONS The Paperwork

210 views • 13 slides

Universal Camera Corp. v. NLRB

Universal Camera Corp. v. NLRB. U.S. Supreme Court 1951. Quotes From Universal Camera.

197 views • 7 slides

Schizophrenia: biological

Schizophrenia: biological. www.psychlotron.org.uk. Genetics Structural brain abnormality Neurochemistry. Schizophrenia: genetics. www.psychlotron.org.uk. Prevalence of schizophrenia is the same all over the world (about 1%)

441 views • 6 slides

Debate Prep

Debate Prep. Debate Prep. You must prepare the following things fo the Debate tomorrow You need a position statement This is an argument that outlines your stance and provide substantial evidence to back it up. This should be pretty long as it is your entire argument.

215 views • 5 slides

Findings of Fact in Formal Proceedings (Rulemakings & Adjudications)

110 views • 0 slides