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FDA Guidances

FDA Guidances

All Information was adapted from the Food and Drug Administration website as a service to our readers. The most current versions can be found on the FDA Website.

Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry

Chronic Obstructive

Pulmonary Disease:

Developing Drugs for

Treatment Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Dr. Badrul A. Chowdhury at 301-796-2300.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Clinical/Medical Revision 1

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Chronic Obstructive

Pulmonary Disease:

Developing Drugs for

Treatment Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Clinical/Medical Revision 1

 

I. II. III.

A.

1. 2.

3. 4. 5.

6.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 DEVELOPMENT PROGRAM ....................................................................................... 3 Overall Considerations .................................................................................................................. 3

Disease Target and Indication.........................................................................................................3 Types of Drugs for COPD................................................................................................................ 3

  1. Improving airflow obstruction .................................................................................................. 3

  2. Providing symptom relief ......................................................................................................... 3

  3. Modifying or preventing exacerbations .................................................................................... 4

  4. Altering disease progression ..................................................................................................... 4

  5. Modifying lung structure........................................................................................................... 4

Drug Development Population ........................................................................................................ 4 Dose Selection.................................................................................................................................. 4 Efficacy Assessment ......................................................................................................................... 5

  1. Objective physiological assessments ........................................................................................ 5

  2. Patient- or evaluator-reported outcome measures..................................................................... 6

  3. Biomarkers and surrogate endpoints ......................................................................................... 7

Recommended Primary and Secondary Efficacy Endpoints............................................................7

  1. Primary efficacy endpoints ....................................................................................................... 7

  2. Secondary efficacy endpoints ................................................................................................... 9

Study Duration.................................................................................................................................9 Number of Studies .......................................................................................................................... 10 Considerations Regarding Demonstration of Efficacy .................................................................. 10

B.

1. 2. 3. 4.

C.

1.

2.

Specific Efficacy Study Considerations...................................................................................... 11

Study Design .................................................................................................................................. 11 Study Populations .......................................................................................................................... 11 Concomitant Treatments................................................................................................................12 Handling of Tobacco Smoking....................................................................................................... 12 Other Considerations................................................................................................................... 12

Drugs Administered by Inhaled Route...........................................................................................12

Combination Drug Products.......................................................................................................... 13

7.
8.
9.
10. Considerations Regarding Demonstration of Safety ................................................................. 10

REFERENCES............................................................................................................................ 14

APPENDIX A: ST. GEORGE’S RESPIRATORY QUESTIONNAIRE IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE STUDIES.......................................................... 15

APPENDIX B: REFERENCES FOR ST. GEORGE’S RESPIRATORY QUESTIONNAIRE..................................................................................................................... 17

CLICK HERE FOR FULL GUIDANCE

 

Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Guidance for Industry

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Procedural

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Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Procedural

CLICK HERE FOR FULL GUIDANCE

 

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) Cheryl Grandinetti at 301-796- 2500, (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240- 402-8010, or CDRH Program Operations Staff at 301-796-5640.

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH)

May 2016 Procedural

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Use of Electronic Health Record Data in Clinical Investigations

Guidance for Industry

Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4
th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research

Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835- 4709 or 240-402-8010
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication and Education
CDRH-Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Room 4621
Silver Spring, MD 20993-0002
Phone: 800-638-2041 or 301-796-7100; Fax: 301-847-8149
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH)

May 2016 Procedural

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I. II. III. IV. V.

A.

B. VI.

A. B. C. D. E.

VII.

Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1

SCOPE ............................................................................................................................... 2

BACKGROUND ............................................................................................................... 3

INTEROPERABILITY .................................................................................................... 4

BEST PRACTICES FOR THE USE OF EHR DATA IN CLINICAL INVESTIGATIONS.......................................................................................................... 5

Use of ONC-Certified Health Information Technology .............................................................6 Use of EHRs Not Certified by ONC ............................................................................................. 6 OTHER GENERAL CONSIDERATIONS FOR BEST PRACTICES ....................... 7 Use of EHRs in Clinical Investigations ........................................................................................ 7 Data Modifications......................................................................................................................... 7 Audit Trails .................................................................................................................................... 8 Informed Consent .......................................................................................................................... 8 Privacy and Security of Data ........................................................................................................ 8

INSPECTION, RECORDKEEPING, AND RECORD RETENTION REQUIREMENTS............................................................................................................ 9


CLICK HERE FOR FULL GUIDANCE

 

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)

 

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)


Act of 2012 (PREA), as amended by FDASIA (Public Law 112-144), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.Total Number of Products Studied under BPCA = 30

Total Number of Products Studied under PREA = 127
Total Number of Products Studied under Both = 4

CLICK HERE FOR FULL ARTICLE

 

 

MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH

 

MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5240.3 Rev. 2

POLICY AND PROCEDURES

OFFICE OF GENERIC DRUGS
Prioritization of the Review of Original ANDAs, Amendments, and Supplements

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PURPOSE

Table of Contents

PURPOSE ..............................................................................1 BACKGROUND ...................................................................1 POLICY .................................................................................2 RESPONSIBILITIES ..........................................................6 PROCEDURES .....................................................................6 EFFECTIVE DATE..............................................................7 CHANGE CONTROL TABLE............................................7

  • This MAPP describes how the review of abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements will be prioritized for review within the Office of Generic Drugs (OGD) and the Office of Pharmaceutical Quality (OPQ).

  • This MAPP is a revision of MAPP 5240.3, Rev. 1, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (August 1, 2014), which revised MAPP 5240.3, Review Order of Original ANDAs, Amendments, and Supplements (October 18, 2006). This MAPP also supersedes MAPP 5240.1, Requests for Expedited Review of Supplements to Approved ANDAs (November 1, 1995). Information relevant to this MAPP is contained in the Draft Guidance for Industry, ANDA Submissions: Amendments and Easily Correctable Deficiencies Pursuant to GDUFA (July 11, 2014) and the Draft Guidance for Industry, Prior Approval Supplements Pursuant to GDUFA (July

    11, 2014).

    CLICK HERE FOR FULL GUIDANCE

 
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