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Data Fda published presentations and documents on DocSlides.

Products Liability 101: Preemption

Products Liability 101: Preemption

  • amey
  • 47 Slides

in Drug & Device Cases. Presented by: Lisa M. ...

Testing Supply Substitution Strategies

Testing Supply Substitution Strategies

  • lucy
  • 22 Slides

This resource is intended for labs performing COVI...

CLINIC UPDATES Ocular Pharmaceutical Developments: Dr. Coral

CLINIC UPDATES Ocular Pharmaceutical Developments: Dr. Coral

  • roy
  • 31 Slides

Pucci. , UMSL. Dr. Coral . Pucci. Dr. Coral . Pucc...

You want me to test for what?

You want me to test for what?

  • joyce
  • 46 Slides

Laboratory Testing During a Pandemic. J. Eric Stan...

Emergency use of a test article / treatment use of investigational drugs

Emergency use of a test article / treatment use of investigational drugs

  • thomas
  • 33 Slides

Emergency use is different than. Expanded Access (...

Should I Use a DCB (Drug Coated Balloon) Here?

Should I Use a DCB (Drug Coated Balloon) Here?

  • mackenzie
  • 24 Slides

Brandon M. Jones, MD. Interventional Cardiology. P...

Gene Therapy and Genome Editing Technology

Gene Therapy and Genome Editing Technology

  • samantha
  • 27 Slides

Peter Marks, MD, PhD. National Press Foundation. N...

Recent U.S. Regulatory Efforts on Complex Innovative Clinical Trial Design

Recent U.S. Regulatory Efforts on Complex Innovative Clinical Trial Design

  • bery
  • 28 Slides

John Scott, Ph.D.. Director, Division of Biostatis...

Making ACE Work for You:

Making ACE Work for You:

  • unita
  • 157 Slides

Importing FDA Regulated Products. Office of Enforc...

Welcome Once you’ve logged into

Welcome Once you’ve logged into

  • dora
  • 43 Slides

Webex. , please select one of the following audio ...

FDA’s Clinical Investigator Course

FDA’s Clinical Investigator Course

  • beatrice
  • 29 Slides

Preparing an IND Application: CBER Breakout Sessi...

medical device cybersecurity

medical device cybersecurity

  • pamela
  • 17 Slides

Seth D Carmody . phD. ACT-IAC cyber COI membership...

JMP for Biosimilars : Tools for Analytical Similarity

JMP for Biosimilars : Tools for Analytical Similarity

  • erica
  • 26 Slides

Sept 16, 2015. W. Heath Rushing, . Adsurgo. LLC. ...

Drug shortages By Mario Motta, MD

Drug shortages By Mario Motta, MD

  • cady
  • 63 Slides

Drug Shortages: a Serious and Widespread Problem. ...

Module 3 Minerals Metallic taste –pregnancy or leaking amalgams

Module 3 Minerals Metallic taste –pregnancy or leaking amalgams

  • della
  • 294 Slides

23/10/18. B2, EFAs. B6. Folic acid, CoQ10, Si. B6....

ClinicalTrials.gov update

ClinicalTrials.gov update

  • kimberly
  • 7 Slides

Public Pressure to Enforce Final Rule. TranspariME...

David Feldman, Ph.D., National Kidney Foundation

David Feldman, Ph.D., National Kidney Foundation

  • madison
  • 37 Slides

James Valentine, J.D., M.H.S., Meeting Moderator. ...

Training and Education: Building a CAPA FDA-Centric Culture

Training and Education: Building a CAPA FDA-Centric Culture

  • ComplianceQuest
  • 100 Slides

Developing a CAPA FDA-centric culture is essential...

10: Information 1 Idea of the Day

10: Information 1 Idea of the Day

  • belinda
  • 71 Slides

2. If every consumer wants at least a minimum le...

Medical Approved Indications Ulcer Active Duodenal Ulcer Healing

Medical Approved Indications Ulcer Active Duodenal Ulcer Healing

  • otis828
  • 21 Slides

has it all…. FDA Approved Indications-2017. . F...

Purpose of Today s Event

Purpose of Today s Event

  • tru
  • 6 Slides

May 16, 2017. Purpose of Today’s Event. Engage i...

Future Data Access and Analysis Architectures - Overview

Future Data Access and Analysis Architectures - Overview

  • marina-yarberry
  • 0 Slides

Dr Robert Woodcock – WGISS 43. CSIRO. Overview....

Understanding Data Registry Setup and Maintenance

Understanding Data Registry Setup and Maintenance

  • alexa-scheidler
  • 0 Slides

Policies. Nichole Haywood. IRB Protocol Analyst. ...

Advanced Data Analytics

Advanced Data Analytics

  • olivia-moreira
  • 0 Slides

in . Fraud Identification. February 23, 2015. Cur...

From Adjuvant to Metastatic in Melanoma This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form.

From Adjuvant to Metastatic in Melanoma This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form.

  • phoebe-click
  • 29 Slides

From Adjuvant to Metastatic in Melanoma This pro...

Understanding Data Registry Setup and Maintenance

Understanding Data Registry Setup and Maintenance

  • joy
  • 37 Slides

Policies. Nichole Haywood. IRB Protocol Analyst. P...

Research

Research

  • luanne-stotts
  • 47 Slides

Integrity:. The . Importance of Data Acquisition ...

A R egulatory Perspective on Threats

A R egulatory Perspective on Threats

  • liane-varnes
  • 17 Slides

to the . Integrity . of . Analgesic Clinical Tria...

Jean L. Patterson, Ph.D.

Jean L. Patterson, Ph.D.

  • alida-meadow
  • 24 Slides

Chair, Department of . Virology. and Immunology....

ASTER One Year Later

ASTER One Year Later

  • luanne-stotts
  • 40 Slides

A New Business Model for Postmarketing Reporting....

SEND Submissions – Quality review by QA – Yes/No?

SEND Submissions – Quality review by QA – Yes/No?

  • danika-pritchard
  • 1 Slides

Daniel Potenta, Michael Wasko, Nina . Häuselmann...

Interpretation Matters: The Wild

Interpretation Matters: The Wild

  • trish-goza
  • 0 Slides

Wild. West of Precision Cancer Medicine. Kenna R...

Indexing SPL Data in Clinical Decision Support Systems

Indexing SPL Data in Clinical Decision Support Systems

  • debby-jeon
  • 0 Slides

Dr. med. A. Leander Fontaine. Pharmiceutics. LLC...

Overview & Enhancement

Overview & Enhancement

  • luanne-stotts
  • 0 Slides

Agenda. Introduction/Timeliness. History of eLEXN...

Standards-Setting in the Context of Regulatory Harmonization

Standards-Setting in the Context of Regulatory Harmonization

  • debby-jeon
  • 0 Slides

Carolyn Compton, M.D., Ph.D.,. CEO and . Presiden...

Lessons Learned: SPL Data Challenges within MedGuide Extraction

Lessons Learned: SPL Data Challenges within MedGuide Extraction

  • pamella-moone
  • 0 Slides

Monday, October 28, 2013 . Ed . Millikan, Pharm.D...

Slide 1 Drug Formulary Commission

Slide 1 Drug Formulary Commission

  • giovanna-bartolotta
  • 0 Slides

Bureau of Health Care Safety and Quality. Departm...

Electronic Technology in Clinical Trials

Electronic Technology in Clinical Trials

  • liane-varnes
  • 0 Slides

1. Leonard Sacks. Office of Medical Policy. CDER....

Standards-Setting in the Context of Regulatory Harmonization

Standards-Setting in the Context of Regulatory Harmonization

  • phoebe-click
  • 0 Slides

Carolyn Compton, M.D., Ph.D.,. CEO and . Presiden...

Nor Cal SOT Evaluation of Carcinogenic Risk for Biotechnology-Derived Therapeutics

Nor Cal SOT Evaluation of Carcinogenic Risk for Biotechnology-Derived Therapeutics

  • danika-pritchard
  • 28 Slides

Nor Cal SOT Evaluation of Carcinogenic Risk for B...

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