In the News Archive

• FDA's HSP/BIMO Initiative Accomplishments: Update May 2012( May 29, 2012)
• Final Rule: Disqualification of a Clinical Investigator( April 30,2012)
• 03/01/2012 FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions (PDF - 108KB)
• 02/01/2012 IRB Continuing Review After Clinical Investigation Approval (PDF - 145KB)
• 02/01/2012 Guidance for Sponsors, Investigators, and Institutional Review Boards - Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c) (PDF - 56KB)
• 08/19/2011 Exculpatory Language in Informed Consent - Draft Guidance (PDF - 112KB)
• HHS Announcement to Extend the Comment Period on Proposal to Improve Rules Protecting Human Research Subjects (Sept. 1, 2011)
• 08/29/2011 Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 149KB)
• 08/15/2011 Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices
• Final Rule: Medical Devices; Exception From General Requirements for Informed Consent (June 24, 2011)
• 08/15/2011 Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novo Classifications
• 07/14/2011 Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices
• Disqualification of a Clinical Investigator; Proposed Rule (Federal Register, Apr. 13, 2011)
• 03/01/2011 Exception from Informed Consent Requirements for Emergency Research (PDF - 341KB)
• Informed Consent Elements Final Rule (Federal Register, Jan. 4, 2011)
• Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
• 10/13/2010 Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB)
• 09/01/2010 FDA’s HSP/BIMO Initiative Accomplishments: Update September 2010
• 06/25/2010 Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)
• 06/01/2010 FDA Inspections of Clinical Investigators - Information Sheet (PDF - 55KB)
• 06/02/2010 Frequently Asked Questions – Statement of Investigator (Form FDA 1572) - Information Sheet (PDF - 105KB)
• 05/01/2010 Clinical Investigator Administrative Actions - Disqualification (PDF - 61KB)
• Proposed Rule - Reporting Information Regarding Falsification of Data (Feb. 19, 2010)
• 01/13/2010 IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 244KB)
• 08/07/2009 FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development
• 10/23/2009 Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)
• 08/12/2009 FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
• Proposed rule - addition of an informed consent required element to 21 CFR 50.25 (Dec. 29, 2009)
• 08/03/2009 FDA, European Medicines Agency Launch Good Clinical Practices Initiative
• 07/09/2009 Frequently Asked Questions - IRB Registration (PDF - 48KB)
• 03/25/2009 FDA's HSP/BIMO Initiative Accomplishments - Update
• 01/01/2009 Adverse Event Reporting to IRBs - Improving Human Subject Protection (PDF - 57KB)
• 10/01/2008 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (PDF - 75KB)
• 04/14/2009 FDA Imposes Restrictions on Coast IRB due to Violations
• FDA Staff Manual Guide, Disqualification of a Clinical Investigator: The Hearing Process (SMG 7711)
• FDA announces availability of documents from the Global Harmonization Task Force (GHTF)
• Final rule on IRB Registration requirements publishes [PDF]
• Final rule on IRB Registration requirements publishes