Good Clinical Practice: Previous "In the News" Items
"In the News" items from previous years can be found in the FDA Archive.
In the News Archive
- FDA Extends the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (December 2018)
- Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (November 15, 2018)
- Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards (October 2018)
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA (May 2018)
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (May 2018)
- Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials, Guidance for Industry (April 2018)
- Payment and Reimbursement to Research Subjects - Information Sheet (January 2018)
- Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs (September 2017)
- FDA Announcement to extend the comment period on the draft guidance document entitled "Informed Consent Information Sheet" (September 2014)
- Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors (July 15, 2014)
- FDA's HSP/BIMO Initiative Accomplishments: Update June 2014
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
- Draft guidance: Humanitarian Device Exemption (HDE): Questions and Answers
- Considerations When Transferring Clinical Investigation Oversight to Another IRB
- Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
- Draft Guidance: Charging for Investigational Drugs Under an IND - Q and As
- Draft Guidance: Expanded Access to Investigational Drugs for Treatment Use - Q and As
- Final Rule: Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (21 CFR Parts 50 and 56) (February 26, 2013)
- Guidance for Clinical Investigators, Industry, and FDA Staff- Financial Disclosure by Clinical Investigators ( February 26, 2013)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff
- Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices (February 25, 2013)
- Guidance for Industry and Food and Drug Administration Staff - Humanitarian Use Device (HUD) Designations (January 2013)
- Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Electronic Source Data in Clinical Investigations
- Considerations When Transferring Clinical Investigation Oversight to Another IRB
- FDA's HSP/BIMO Initiative Accomplishments: Update May 2012( May 29, 2012)
- Final Rule: Disqualification of a Clinical Investigator( April 30,2012)
- FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions
- IRB Continuing Review After Clinical Investigation Approval
- Guidance for Sponsors, Investigators, and Institutional Review Boards - Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c)
- Exculpatory Language in Informed Consent - Draft Guidance
- HHS Announcement to Extend the Comment Period on Proposal to Improve Rules Protecting Human Research Subjects (Sept. 1, 2011)
- Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
- Final Rule: Medical Devices; Exception From General Requirements for Informed Consent (June 24, 2011)
- Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
- Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry, and FDA Staff
- Draft 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)
- Exception from Informed Consent Requirements for Emergency Research
- Informed Consent Elements Final Rule (Federal Register, Jan. 4, 2011)
- Electronic Source Documentation in Clinical Investigations
- 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
- Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND
- FDAâs HSP/BIMO Initiative Accomplishments: Update September 2010
- Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
- FDA Inspections of Clinical Investigators - Information Sheet
- Frequently Asked Questions â Statement of Investigator (Form FDA 1572) - Information Sheet
- Clinical Investigator Administrative Actions - Disqualification
- Proposed Rule - Reporting Information Regarding Falsification of Data (Feb. 19, 2010)
- IRB Continuing Review After Clinical Investigation Approval - Draft Guidance
- FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development
- Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
- 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)
- FDA, European Medicines Agency Launch Good Clinical Practices Initiative
- Frequently Asked Questions - IRB Registration
- FDA's HSP/BIMO Initiative Accomplishments - Update
- Adverse Event Reporting to IRBs - Improving Human Subject Protection
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Information Sheet
- 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
- The 2009 edition of the International Compilation of Human Subject Protections