FOOD AND DRUG ADMINISTRATION (FDA)

FDA APPROVED DRUG PRODUCTS (The "Orange Book")

SIGNING THE FDA 1572 FORM: WHAT ARE YOUR COMMITMENTS?

FDA REGULATIONS AND INFORMATION REGARDING PROTECTION OF HUMAN RESEARCH SUBJECTS


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FDA HOMEPAGE

FDA OFFICE HUMAN RESEARCH TRIALS

FDA CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

FDA CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

APPLICATION PROCESS

GOOD CLINICAL PRACTICES (GCP)

FDA OFFICE OF REGULATORY AFFAIRS

FDA DEBARMENT LISTS

FDA FORMS

FDA INFORMATION ESSENTIAL FOR CLINICAL TRIALS

SMALL BUSINESS GUIDE TO FDA



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FDA INFORMATION ESSENTIAL FOR CLINICAL TRIALS

FDA Information Sheets

FDA Contacts for Clinical Trials

FDA Regulations and Information Regarding Protection of Human Research Subjects

FDA Form 1572: What Do the Nine Commitments That Investigators Affirms Mean? (via Children's Hospital in Philadelphia)

Clinical Trials and Human Subject Protection

Good Clinical Practices (GCP) in FDA-Regulated Clinical Trials

FDA List of Disqualified / Restricted Clinical Investigators (PIs must verify that no project staff are on this list)

Federal Regulations for Clinical Investigators

FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drugs (via U. KY)

FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices (via U. KY)

 

FDA HOMEPAGE

FDA Forms Download Page

Clinical Investigator Forms (e.g., FDA1571 and FDA1572)

FDA News

FDA Regulatory Guidance & Enforcement Information (via CDER)

FDA Freedom of Information Page

FDA Warning Letters

By Subject [Try "C" for Clinical Investigator, or "I" for Institutional Review Board]

 

ADVERSE EVENT REPORTING TO THE FDA

What is a Serious Adverse Event?

MedWatch

MedWatch Form for Voluntary Reporting (Form 3500)

Instructions for Completing MedWatch Form

MedWatch Form 3500 Online

 

FDA OFFICE FOR HUMAN RESEARCH TRIALS

Compliance Oversight

Educational Materials

Guidances and Information Sheets on Human Subject Protection and Good Clinical Practice

Important FDA Contacts for IRBs and Clinical Investigators

Proposed Regulations and Draft Guidances on Human Subject Protection and Good Clinical Practice

Regulations Relating to Human Subject Protection and Good Clinical Practice

Reporting Complaints Related to Human Subject Protection/Good Clinical Practice in FDA-Regulated Clinical Trials

 

FDA CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CBER Guidance / Guidelines / Points to Consider

Information on Submitting an Investigational New Drug Application (IND) For a Biological Product

Publications

 

FDA CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Guidance Documents

Approved Drug Products (The "Orange Book")

Compliance Activities (Includes Warning Letters to Pharmaceutical Companies)

FDA Information Sheets: Guidance for Clinical Investigators and IRBs

Information for Clinical Investigators

Clinical Investigator Forms (e.g., FDA1571 and FDA1572)

Good Clinical Practices (GCP)

Good Clinical Practice in FDA-Regulated Clinical Trials

Good Clinical Practices (GCP)

Good Clinical Practice (GCP) Consolidated Guidelines from International Conference on Harmonisation (ICH)

FDA Guidance On International Conference on Harmonization (ICH) GCP Guidelines (via US FDA)

Clinical Monitoring -- GCP Q&A (Applied Clinical Trials - July, 2003)

Drug Approval Application Process

Investigational New Drug (IND) Application Process

New Drug Application (NDA) Process

Guidance Documents for Drug Applications

Drug Development and Review Definitions

FAQ on Drug Development and the IND Application Process

FDA Oncology Tools

FDA Policies & Publications Related to Cancer

Regulatory Guidance

Adverse Event Reporting System

INVESTIGATIONAL DRUGS

"Off-Label" and Investigational Use of Marketed Drugs, etc. (via FDA)

Emergency Use of Investigational Drugs or Biologics (via FDA)

From Test Tube to Patient: New Drug Development in the U.S. (via FDA)

The New Drug Development Process

The IND Review Process

The NDA Review Process

FDA - Submission of an IND to the Office of Generic Drugs


Investigational New Drug (IND) Application Process

Information from the FDA

Interactive Flow-Chart Describing IND Review Process

FDA - IND Process and Review Procedures

 

FDA OFFICE OF REGULATORY AFFAIRS (ORA)

Compliance References: Bioresearch Monitoring

Frequently Requested ORA Documents

Compliance Warning Letters to Investigators, etc.

Investigations Operations Manual

 

FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

FAQ: Humanitarian Device Exemption Regulations

CDRH Databases

CDRH Guidance Documents Index

CDRH IRB Information Sheets

CDRH Regulatory Manuals

Recent Medical Device Approvals

Significant Risk and Non-Significant Risk Medical Device Studies

Device Advice (Site Index)

Device Advice (Getting Started)

Is My Product Regulated by FDA CDRH?

Premarket Notification [510(k)]

How to Locate 510(k) Guidance Documents

Medical Device Exemptions [510(k) and GMP Requirements]

Getting to Market with a Medical Device

FDA Device Product Code Database

FDA DEBARMENT LISTS

FDA List of Disqualified / Restricted Clinical Investigators (PIs must verify that no project staff are on this list)

Firms and Persons Debarred Under Federal Food, Drug and Cosmetic Act

 

FDA FORMS

DHHS PSC Forms Download Site for FDA Forms

FDA Forms Page [ PDF Versions] [ Word Versions]

CBER Forms

CDER Forms

CDRH Forms

 

SMALL BUSINESS GUIDE TO FDA


Page Updated: 6/7/2004

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