Thursday, January 31, 2013

NEW & REVISED DRAFT GUIDANCE CDER FDA PLANS TO PUBLISH in 2013: COMPOUNDING IS ON THE LIST


Guidance Agenda:
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2013
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY — Advertising

Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials including Submissions in Electronic Format
CATEGORY — Animal Rule

Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics

Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration
CATEGORY — Biosimilarity

Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products
CATEGORY — Chemistry

Allowable Excess Volume and Labeled Vial Fill Size

Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in Abbreviated New Drug Applications

CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological Products

Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information

Elemental Impurities in Drug Products Marketed in the United States

Immunogenicity Considerations for Low Molecular Weight Heparin

Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation

Size and Physical Attributes of Generic Tablets
Version: 01.31.13
CATEGORY — Clinical/Antimicrobial

Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of Serious Bacterial Diseases

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment

Pulmonary Tuberculosis: Developing Drugs for Treatment
CATEGORY — Clinical/Medical

Alzheimer’s Disease: Developing Drugs for the Treatment of Early State Disease

Common Issues in Drug Development for Rare Diseases

Developing Drug and Biological Products for Analgesic Indications

Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)

Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
CATEGORY – CMC and CLINICAL/MEDICAL

Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY — Clinical Pharmacology

Bioanalytical Methods Validation

Clinical Pharmacogenomics: Study Design and Premarketing Evaluation

Clinical Pharmacology Consideration for Therapeutics Proteins

General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological Products
CATEGORY — Clinical/Statistical

Multiple Endpoints in Clinical Trials
CATEGORY — Current Good Manufacturing Practices (CGMPs)/Compliance

Quality Systems Approach to Pharmaceutical cGMP Regulation (OMPQ)

Uniformity of In-Process Mixtures (OMPQ)

Control of Highly Potent Compounds (OMPQ)

Contract Manufacturing Arrangements for Drugs: Quality Agreements

Submission of Field Alert Reports and Biological Product Deviation Reports (OMPQ)

Pre-Launch Activities Importation Request (PLAIR)
Version: 01.31.13
CATEGORY — Drug Safety Information

Best Practices in Developing Proprietary Names to Minimize Medication Errors

Providing Postmarket Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)

Safety Considerations in Product Design to Minimize Medication Errors.

Securing the Drug Supply Chain—Standards for Tracking and Tracing Prescription Drug Packages

Safety Considerations for Container Label and Carton Labeling Design to Minimize Medication Errors
CATEGORY — Electronic Submissions

Providing Regulatory Submissions in Electronic Format – General Considerations

Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports

Providing Regulatory Submissions in Electronic Format – Standardized Study Data

Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning

Providing Submissions in Electronic Format – Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers
CATEGORY — IND

Adverse Events: Collection and Reporting for Secondary Endpoints
CATEGORY — Labeling

Drug Names and Dosage Forms

Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
CATEGORY – Pharmacology/Toxicology

Endocrine Disruption Potential of Drugs: Non Clinical Evaluation
CATEGORY — Procedural

Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)

Expedited Programs for Serious Conditions, Drugs and Biologics

Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants

Integrated Summary of Safety

Investigational New Drug Applications prepared and submitted by Clinical Sponsor Investigators

Pediatric Product Development
Version: 01.31.13
Version: 01.31.13

Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Public Disclosure of FDA-Sponsored Studies

Prescription Drug Marketing Act (PDMA) Requirements

Reporting Drug Sample Distribution Under Section 6004 of the Affordable Care Act

Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies

Electronic Source Data in Clinical Investigations
Note: Agenda items reflect guidances under development as of the date of this posting.

Source found  here

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