Source: https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/proposedregulationsanddraftguidances/default.htm
Timestamp: 2019-01-18 17:29:33
Document Index: 348954302

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'arts 312', 'art 11', 'art 312', 'art 312', 'art 312']

12/20/2018: FDA Extends the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that appeared in the Federal Register of November 15, 2018. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. The proposed rule can be accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-11-15/pdf/2018-24822.pdf. Comments on the proposed rule may be submitted at https://www.regulations.gov (Docket No. FDA-2018-N-2727).
Comments are due by February 13, 2019.
11/15/2018: Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
FDA is proposing to amend its regulations to implement section 3024 of the 21st Century Cures Act. This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
Comments are due by January 14, 2019.
9/20/2018: Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
The Food and Drug Administration has issued the draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." The guidance is intended for FDA staff, responsible parties, and submitters of certain applications and submissions to FDA.
This guidance document is intended to describe the current thinking of FDA regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR Part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.
Comments due by November 20, 2018
04/09/2018: Draft Guidance - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials
Comments are due by June 8, 2018.
6/21/2017: Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11- Questions and Answers
This draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations.
Comments due by August 21, 2017.
04/22/2015: Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance focuses on FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States.
Comments due by July 20, 2015.
07/15/2014: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors (Draft)
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency’s recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance describes the basic and additional elements of informed consent and includes topics such as review of patient records, children as subjects, and subject participation in more than one study.
The comment period for the draft guidance published July 25, 2014 is extended. Comments will be received through October 27, 2014.
3/18/2014: Draft guidance: Humanitarian Device Exemption (HDE): Questions and Answers
Comments due by May 19, 2014.
5/9/2013: Draft Guidance: Charging for Investigational Drugs Under an IND - Q&As
This draft guidance is intended to provide information for industry, researchers, and physicians about the implementation of FDA’s regulation on charging for investigational drugs under an Investigational New Drug Application (IND) (21 CFR 312.8), which went into effect on October 13, 2009. It includes information concerning charging for investigational drugs made available under expanded access programs.
Comments are due by July 8, 2013
5/9/13: Draft Guidance: Expanded Access to Investigational Drugs for Treatment Use - Q&As
This draft guidance is intended to provide information for industry, researchers, physicians, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009.
2/25/2013: Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
12/17/2012: Draft Guidance for Industry Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Similar strategies may also be useful in studies conducted in earlier stages of development.
Comments are due by February 15, 2013
11/20/2012: Guidance for Industry Electronic Source Data in Clinical Investigations
This draft guidance document provides recommendations to sponsors, Contract Research Organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This draft guidance document promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.
Comments are due by January 22, 2013
9/7/2011: Guidance on Exculpatory Language in Informed Consent
7/26/2011: Advanced Notice of Proposed Rule Making - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
6/1/2011: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions, Draft Guidance for Industry and FDA Staff
This draft guidance document is intended to clarify the types of in vitro diagnostic (IVD) products that are properly labeled “for research use only” ("RUO") or “for investigational use only” ("IUO"), and provide the responses of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) to some frequently asked questions about how such products should and should not be marketed. This document is intended for manufacturers and distributors of RUO and IUO IVD products and any other entities who label IVD products.
Comments are due by August 30, 2011
10/14/2010: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB)
This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new drug application (IND), as described in Title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND regulations.
Comments are due January 12, 2011
2/19/2010: Proposed rule - Reporting Information Regarding Falsification of Data
The proposed rule will require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigations, nonclinical laboratory studies, and clinical studies in animals.
11/28/06: FDA Extends the Comment Period on the Draft Guidance for Industry, Clinical Laboratories and FDA Staff on In Vitro Diagnostic Multivariate Index Assays [PDF107 KB]
Written or electronic comments on this draft guidance will be accepted until March 5, 2007.
1/17/06: Withdrawal of the Advance Notice of Proposed Rulemaking entitled "Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Boards Reviews"
After reviewing public comments on this ANPRM, FDA concluded that rulemaking on this matter was not warranted at this time. A notice withdrawing this ANPRM published in the Federal Register on Jan. 16, 2006. This notice can be found on FDA's Dockets Management Web site at www.accessdata.fda.gov/scripts/oc/ohrms/frbydocket.cfm.
The effective date for this withdrawal is February 16, 2006.
1/27/04: FDA published a Notice of Availability announcing the availability of a draft guidance entitled "Information Program on Clinical Trials for Seriousor Life-Threatening Diseases and Conditions"
FDA is revising its March 2002 guidance for industry of the same title to include guidance for sponsors who will be submitting information required by the Best Pharmaceuticals for Children Act. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments for Docket No. 2004D-0014 must be submitted by March 29, 2004.