Talk:List of Guidances for Statistics in Regulatory Affairs

Welcome

Statisticians working in a regulated environment (e.g. the pharmaceutical and healthcare industry) are obliged to have a sound knowledge and understanding of the regulatory requirements that affect the design, conduct, analysis and reporting of their studies.

Regulatory guidance for the pharmaceutical and medical devices industry can be found at the international level (e.g. ICH), as well as at the regional/national level (e.g. EMA in Europe, NICE in UK, IQWiG in Germany, FDA in USA and PMDA in Japan). Furthermore, statistical regulatory guidance is found under general topics (e.g. Good Clinical Practice [ICH-E6]) and specific ones explicitly related to statistics (e.g. Statistical Principles for Clinical Trials [ICH-E9]) or not explicitly (e.g. Special Populations: Geriatrics [ICH-E7] or Clinical Trial Endpoints in Oncology [FDA]). This large volume and diversity of documents and information sources is subject to regular revisions. Hence, individual statisticians devote considerable time and effort to keep themselves adequately informed and educated about regulatory requirements.

The objective of this list is to initiate in Wikipedia a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs.

[Wikipedia:Talk_page_guidelines]

Content guidance

This section presents recommendations about the format that should be used to include a document references within this article. The easiest to add new references is to copy an paste any of the previous references already included. The references include de following syntax.

• Bullet point
• Title of the document
• Reference
• Specify between parenthesis the regulatory agency
• And finally provide a brief summary about the guidance and why and statistician should know about the content.

Example:

• CHMP/EWP/5872/03 Data monitoring committees (EMA) deals with independent data monitoring committees. It highlights the key issues involved when sponsors include data monitoring committees as a part of their trial management, and the involvement of all the members including statisticians.

If you have any questions, feel free to ask to any of the contributors by adding your comments on the the bottom of the talk page, on the section Open Discussion.

References

To do list

FDA Guidances

There is a large list of FDA guidances that should be included here: http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/general/ucm217041.htm

I make a copy of the guidances, please, if anybody includes any of this document, remove it from the list:

• Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (PDF - 336KB) CDRH, CDER, CBER, OMPT, February 2016
• Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 140KB) CDER/CBER, February 2016
• Rare Diseases: Common Issues in Drug Development; Draft Guidance for Industry (PDF - 306KB) CDER/CBER, August 2015
• Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 343KB) CDER/CBER, April 2015
• Clinical Trial Imaging Endpoint Process Standards; Draft Guidance (PDF - 675KB) CDER/CBER, March 2015
• S10 Photosafety Evaluation of Pharmaceuticals; Guidance for Industry (PDF - 256KB) CDER/CBER, January 2015
• Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption Clinical Investigations (PDF - 631KB) CDRH/CBER, August 2014
• Draft Guidance for IRBs, Clinical Investigators, and Sponsors - Informed Consent Information Sheet CDER/CBER/CDRH, July 2014
• Guidance for Clinical Investigators, Sponsors, and IRBs; Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 305KB) CDER/CBER, September 2013
• Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 501KB) CDER/CBER, May 2013
• Guidance for Industry: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF - 131KB) CDER/CBER/CDRH, January 2013
• Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF - 997KB) CDER/CBER/CDRH, December 2012
• Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals (PDF) (PDF - 359KB) CDRH/CBER, October 2012
• Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions (PDF - 108KB) CDER/CBER, March 2012
• Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers (PDF - 104KB) CDER/CBER, February 2012
• Draft Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 140KB) CDER/CBER, February 2012
• Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 343KB) CDER/CBER, June 2011
• Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB) CDER/CBER, April 2011
• Guidance for Industry and Researchers: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 6.8MB) CDER/CBER, August 2010
• Draft Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 976KB) CDER/CBER, March 2010
• Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 423KB) CDER/CBER, February 2010
• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (PDF - 388KB) CDRH/CBER, February 2010
• Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB) CDER/CBER, July 2009
• Draft Guidance for Industry: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF - 28KB) CDER/CBER, January 2009
• Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection (PDF - 61KB) OC/CDER/CBER/CDRH/GCPP, January 2009
• Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB) CDRH/CBER, December 2008
• Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 144KB) CDER/CBER, May 2007
• Guidance for Industry: Computerized Systems Used in Clinical Investigations (PDF - 53KB) FDA/OC, May 2007
• Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF) (PDF - 95KB) CDRH/CBER, October 2006
• Guidance for Industry and FDA Staff: Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF Version) (PDF - 82KB) CDRH/CBER, April 2006
• Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB) CDER/CBER, January 2006
• Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 165KB) CDRH/CBER, May 2005
• Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CDRH/CBER, November 2004
• Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB) CDRH/CBER, November 2004
• Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF) (PDF - 162KB) CDRH/CBER, May 2004
• Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB) CDER/CBER, October 2000
• Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB) CDER/CBER/CDRH, July 1999
• Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB) CDER/CBER/CDRH, February 1999
• Guidance for Industry: Population Pharmacokinetics (PDF - 135KB) CDER/CBER, February 1999
• Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB) CDER/CBER, November 1995

--Jvtorres (talk) 11:41, 2 July 2016 (UTC)

Open Discussion

This is an open space for everybody to discuss about the content of this article. Jvtorres (talk) 10:40, 24 July 2016 (UTC)