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FDA Guidances - PharmaFacts
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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.

Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry

Osteoporosis:

Nonclinical Evaluation

of Drugs Intended 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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Samantha Bell at 301-796-9687.

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

June 2016 Pharmacology/Toxicology

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15004dft.doc 06/01/16

Osteoporosis:

Nonclinical Evaluation

of Drugs Intended 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)

June 2016 Pharmacology/Toxicology

 

I. II. III.

A. B.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 NONCLINICAL STUDIES.............................................................................................. 2 Toxicology Studies ......................................................................................................................... 2 Bone Quality Studies...................................................................................................................... 2

1. Animal Species and Models ............................................................................................................. 2

  1. Two-species requirement .......................................................................................................... 2

  2. Osteoporosis models ................................................................................................................. 3

  3. Studies to support other osteoporosis indications ..................................................................... 3

2. Study Design .................................................................................................................................... 3

  1. Dose selection ........................................................................................................................... 3

  2. Dosing regimen and administration route.................................................................................3

  3. Study duration ........................................................................................................................... 4

  4. Data analysis ............................................................................................................................. 4

3. Evaluations ...................................................................................................................................... 4

  1. Bone turnover ............................................................................................................................ 4

  2. Bone mass and density..............................................................................................................4

  3. Bone structure and architecture................................................................................................. 4

  4. Bone strength ............................................................................................................................ 5

  5. Additional evaluations .............................................................................................................. 5

Biopharmaceuticals ....................................................................................................................... 6

REGULATORY ASPECTS............................................................................................. 6

C. IV.

V. REFERENCES.............................................................................................................................. 8

CLICK FOR FULL GUIDANCE

 

E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

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For questions regarding this draft document contact (CDER) Christian Grimstein 301-796-5189 or (CDRH) Eunice Lee 301-796-4808.

INTERNATIONAL CONCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

E18

Current Step 2 version dated 10 December 2015

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.

E18 Document History

Code

History

Date

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E18

Approval by the ICH Assembly under Step 2 and release for public consultation.

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10 December 2015

Legal notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.

The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document.
The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.

 

1

2 3

4 5 6 7

8

9 1. 10 1.1. 11 1.2. 12 1.3. 13 1.4. 14 2. 15 2.1. 16
17
18
19
20
21
22
23 2.2. 24
25
26
27
3. 28 3.1. 29 3.2.

ICH HARMONISED GUIDELINE

GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

E18
Draft ICH Consensus Guideline
Released for Consultation on 10 December 2015, at Step 2 of the ICH Process

TABLE OF CONTENTS

INTRODUCTION .......................................................................................................... 5

Objectives of the Guideline .............................................................................................. 5 Background ....................................................................................................................... 5 Scope of the Guideline ...................................................................................................... 6 General Principles ............................................................................................................. 6 GENOMIC SAMPLING................................................................................................ 7 Collection and Processing of Samples .............................................................................. 7 2.1.1. Specimen Type .................................................................................................. 8 2.1.2. Timing of Specimen Collection......................................................................... 8 2.1.3. Specimen Preservation Conditions .................................................................. 8 2.1.4. Specimen Stability and Degradation................................................................ 9 2.1.5. Specimen Volume and Composition ................................................................. 9 2.1.6. Parameters Influencing Genomic Sample Quality ........................................... 9 2.1.7. Sources of Interference ................................................................................... 10 Transport and Storage of Samples ................................................................................ 10 2.2.1. Transport of Samples...................................................................................... 10 2.2.2. Storage of Samples ..........................................................................................11 2.2.3. Curation of Sample Inventory .........................................................................11 GENOMIC DATA..........................................................................................................11 Generation of Genomic Data .......................................................................................... 12 Handling and Storage of Genomic Data ......................................................................... 12

30 31 32 33 34

4. PRIVACYANDCONFIDENTIALITY......................................................................13

4.1. Coding of Samples and Data........................................................................................... 13 4.2. Access to Genomic Samples and Data............................................................................ 13 5. INFORMED CONSENT .............................................................................................. 14 6. TRANSPARENCY AND COMMUNICATION OF FINDINGS.............................. 14

 

Charging for Investigational Drugs Under an IND — Questions and Answers Guidance for Industry

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Charging for Investigational Drugs Under an IND —

Questions and Answers Guidance for Industry

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)

June 2016 Procedural

page1image4008

Charging for Investigational Drugs Under an IND — Questions and Answers

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

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

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)

June 2016 Procedural

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I. II. III.

A. B. C. D.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 QUESTIONS AND ANSWERS....................................................................................... 2 General Questions .......................................................................................................................... 2 Charging in Clinical Trials ........................................................................................................... 3 Charging For Expanded Access Use ............................................................................................ 6 Cost Recovery Calculations .......................................................................................................... 7

CLICK HERE FOR FULL GUIDANCE

 

Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry

Safety Considerations for Product Design to Minimize Medication Errors

Guidance for Industry

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

April 2016 Drug Safety

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Safety Considerations for Product Design to Minimize Medication Errors

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

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

April 2016 Drug Safety

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I. II.

A.

B. III.

A.

B. IV.

A. B.

Table of Contents

INTRODUCTION .............................................................................................................. 1 BACKGROUND ................................................................................................................ 2 Recommendations to Minimize Medication Errors ............................................................ 3 Safety by Design: A Systems Approach to Medication Error Prevention......................... 4 WHAT TO CONSIDER AT EARLY STAGE OF DRUG PRODUCT DESIGN TO MINIMIZE MEDICATION ERRORS............................................................................... 4 End Users and Environments of Use .................................................................................. 6 Drug Product-User Interface ............................................................................................... 8 PROACTIVE RISK ASSESSMENTS ............................................................................. 15 Failure Mode and Effects Analysis ................................................................................... 16 Simulated Use Testing ...................................................................................................... 17 CONCLUSION................................................................................................................. 17

Contains Nonbinding Recommendations

V.
GLOSSARY ......................................................................................................................... 19

CLICK HERE FOR FULL GUIDANCE

 

Contents of a Complete Submission for the Evaluation of Proprietary Names Guidance for Industry

Contents of a Complete

Submission for the

Evaluation of

Proprietary Names Guidance for Industry

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)

April 2016 Labeling

Revision 1

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Contents of a Complete

Submission for the

Evaluation of Proprietary

Names 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 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

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

April 2016 Labeling

Revision 1

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I. II.

A. B. C. D. E.

III. IV.

A. B. C. D. E.

V. A.

B.

TABLE OF CONTENTS

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

BACKGROUND ............................................................................................................... 2

Recommendations to Minimize Medication Errors.................................................................... 2

Medication-Use Systems ................................................................................................................ 4

Proprietary Name Confusion and Medication Errors................................................................ 4

FDA’s Approach to the Evaluation of Proposed Proprietary Names ....................................... 5

Regulatory Authority..................................................................................................................... 7

PDUFA IV GOAL DATES .............................................................................................. 8

CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF PROPOSED PROPRIETARY NAMES ......................................................................... 9

General Information ...................................................................................................................... 9

Proposed Proprietary Name ....................................................................................................... 10

Additional Information about the Product................................................................................ 11

Information about Product Dispensing and Delivery ............................................................... 14

Independent Assessments of Proprietary Name, Packaging, and/or Labeling ...................... 15

WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED PROPRIETARY NAME REVIEW .............................................................................. 15

Contains Nonbinding Recommendations

Drug Products, Including Biologics, That Are the Subject of an IND, NDA, or BLA — Paper Submission......................................................................................................................... 15 Drugs Products That Are the Subject of an ANDA — Paper Submission ............................. 16 Electronic Submissions ................................................................................................................ 16

C. GLOSSARY................................................................................................................................. 18

CLICK HERE FOR FULL GUIDANCE

 
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