CDER GUIDANCES 2011- NEW/REVISED/WITHDRAWN - Barry A. Friedman, PhD LLC

During 2011 CDER released a number of new Guidance for Industry documents.Â Many of these documents are quite difficult to locate within knowing the exact name of the document.Â These documents include the very widely publicized Process Validation (January 2011), several relating to PET (Positron Emission Tomography) products and their approvals, as well as many other documents that did not achieve the status of these.

Please review these various Guidances to determine if any of this information may be of value to your organization.

(Sorted by date)

Title

Subject

Level at Date of Issue

Publication/ Withdrawal Date

Status

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

Procedural Draft

Level 1

1/7/2011

Revised

Size of Beads in Drug Products Labeled for Sprinkle

Chemistry, Manufacturing, and Controls Draft

Level 1

1/19/2011

New

Process Validation: General Principles and Practices

Current Good Manufacturing Practices

Level 1

1/25/2011

New

Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review

Drug Safety/ Good Review Practices

Level 1

1/26/2011

Withdrawn

PET Drug Applications â€“ Content and Format for NDAsÂ and ANDAs

Procedural/ Modernization Act Draft

Level 1

2/2/2011

New

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Drug Safety Draft

Level 1

2/16/2011

New

Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Clinical Pharmacology Draft

Level 1

2/18/2011

New

Medication Guides–Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies

Drug Safety Draft

Level 1

2/28/2011

New

User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

User Fees Draft

Level 1

3/14/2011

New

Non-Penicillin Beta-LactamÂ Risk Assessment: A CGMP Framework

Current Good Manufacturing Practices Draft

Level 1

3/15/2011

New

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

Labeling

Level 1

3/15/2011

New

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Procedural

Level 1

3/15/2011

New

Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act

Drug Safety

Level 1

4/1/2011

New

ClozapineÂ Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing

Biopharmaceuticals

Level 1

4/1/2011

Withdrawn

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research

Clinical/Medical

Level 1

4/4/2011

New

Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

Drug Safety Draft

Level 1

4/13/2011

New

Influenza: Developing Drugs for Treatment and/or Prophylaxis

Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products	Current Good Manufacturing Practices	Level 1	5/5/2011	New
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications	Generics	Level 1	5/6/2011	New
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry, and FDA Staff	Procedural Draft	Level 1	5/24/2011	New
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act	Procedural	Level 1	6/8/2011	New
Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application	Procedural Draft	Level 1	6/14/2011	New
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics	Clinical Medical Draft	Level 1	6/16/2011	New
Topical Acne Drug Products for Over-the-Counter Human Use–Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective	Labeling; OTC; Small Entity Compliance Guides	Level 1	6/21/2011	New
Guideline on Validation of the Limulus Amebocyte Lysate Test	Current Good Manufacturing Practices	Level 1	6/22/2011	Withdrawn
Q4BÂ Evaluation and Recommendation of PharmacopoeialÂ Texts for Use in the ICH Regions Annex 7(R2) Dissolution Test General Chapter	ICH Quality	Level 1	6/23/2011	Revised
Q11 Development and Manufacture of Drug Substances	ICH Quality Draft	Level 1	6/28/2011	New
PET Drugs â€” Current Good Manufacturing Practice (CGMP) (Small Entity Compliance Guide)	cGMP/Compliance; Small Entity Compliance Guides	Level 1	8/4/2011	New
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions	ICH Efficacy	Level 1	8/10/2011	New
Residual Drug in Transdermal and Related Drug Delivery Systems	Chemistry, Manufacturing, and Controls Draft	Level 1	8/16/2011	New
Standards for Clinical Trial Imaging Endpoints	Clinical/Medical Draft	Level 1	8/18/2011	New
E2F Development Safety Update Report	ICH Efficacy	Level 1	8/22/2011	New
Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention	Clinical/Antimicrobial Draft	Level 1	8/23/2011	New
Oversight of Clinical Investigations â€” A Risk-Based Approach to Monitoring	Procedural Draft	Level 1	8/29/2011	New
Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation	Chemistry, Manufacturing, and Controls Draft	Level 1	8/29/2011	New
PET Drug Applications â€” Content and Format for NDAsÂ and ANDAs, Fludeoxyglucose F 18 Injection, Ammonia N 13 Injection, Sodium Fluoride F 18 Injection	Procedural; Modernization Act	Level 1	8/31/2011	New

PET Drug Applications – Content and Format for NDAsÂ and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011	Procedural; Modernization Act	Level 1	8/31/2011	New
Self-Selection Studies for Nonprescription Drug Products	OTC Draft	Level 1	9/16/2011	New
Marketed Unapproved Drugs — Compliance Policy Guide	Current Good Manufacturing Practices/ Compliance	Level 1	9/19/2011	Revised
Reproductive and Developmental Toxicities — Integrating Study Results to Assess Concerns	Pharm/Tox	Level 1	9/22/2011	New
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products	User Fees	Level 1	9/26/2011	New
Time and Extent Applications for Nonprescription Drug Products	OTC	Level 1	9/28/2011	New
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography	Current Good Manufact. Practices/ Compliance Draft	Level 1	9/29/2011	New
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))	Current Good Manufacturing Practices/ Compliance	Level 1	10/3/2011	Withdrawn
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products â€” Content and Format	Labeling	Level 1	10/11/2011	New
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting	Chemistry, Manufacturing, and Controls	Level 1	10/11/2011	New
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)	Labeling Draft	Level 1	10/17/2011	Withdrawn/ Moved
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide â€” Data Elements and Message Specification; and Appendix to the Implementation Guide â€” Backwards and Forwards Compatibility	ICH Efficacy Draft	Level 1	10/19/2011	New
Q8, Q9, and Q10 Questions and Answers	ICH Quality	Level 1	11/1/2011	Revised
Medication Guides â€” Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies	Drug Safety	Level 1	11/17/2011	New
NonclinicalÂ Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals	Pharm/Tox	Level 1	11/25/2011	New
Regulatory Classification of Pharmaceutical Co-Crystals	Chemistry, Manufacturing, and Controls Draft	Level 1	12/1/2011	New
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices	Procedural Draft	Level 1	12/27/2011	New
Use of Histology in Biomarker Qualification Studies	Procedural Draft	Level 1	12/29/2011	New

PET Drug Applications – Content and Format for NDAsÂ and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011	Procedural; Modernization Act	Level 1	8/31/2011	New
Self-Selection Studies for Nonprescription Drug Products	OTC Draft	Level 1	9/16/2011	New
Marketed Unapproved Drugs — Compliance Policy Guide	Current Good Manufacturing Practices/ Compliance	Level 1	9/19/2011	Revised
Reproductive and Developmental Toxicities — Integrating Study Results to Assess Concerns	Pharm/Tox	Level 1	9/22/2011	New
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products	User Fees	Level 1	9/26/2011	New
Time and Extent Applications for Nonprescription Drug Products	OTC	Level 1	9/28/2011	New
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography	Current Good Manufact. Practices/ Compliance Draft	Level 1	9/29/2011	New
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))	Current Good Manufacturing Practices/ Compliance	Level 1	10/3/2011	Withdrawn
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products â€” Content and Format	Labeling	Level 1	10/11/2011	New
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting	Chemistry, Manufacturing, and Controls	Level 1	10/11/2011	New
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)	Labeling Draft	Level 1	10/17/2011	Withdrawn/ Moved
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide â€” Data Elements and Message Specification; and Appendix to the Implementation Guide â€” Backwards and Forwards Compatibility	ICH Efficacy Draft	Level 1	10/19/2011	New
Q8, Q9, and Q10 Questions and Answers	ICH Quality	Level 1	11/1/2011	Revised
Medication Guides â€” Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies	Drug Safety	Level 1	11/17/2011	New
NonclinicalÂ Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals	Pharm/Tox	Level 1	11/25/2011	New
Regulatory Classification of Pharmaceutical Co-Crystals	Chemistry, Manufacturing, and Controls Draft	Level 1	12/1/2011	New
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices	Procedural Draft	Level 1	12/27/2011	New
Use of Histology in Biomarker Qualification Studies	Procedural Draft	Level 1	12/29/2011	New

Clinical/Antimicrobial

Level 1

4/13/2011

New

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