Monday 4 March 2013

FDA guidance documents for 2013

Guidance Agenda: New & Revised Draft Guidances CDER is  Planning to Publish During Calendar Year 2013

FDA has released a list of more than 50 guidance documents planned for 2013. The list reflects guidance documents currently under development as of the date of the posting, Jan. 31, 2013.

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---Bioav ailability 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 Pharmacokine tic Endpoints for Drug Products Submitted in  Abbreviate 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

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


• 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 Manufactur ing 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)

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


• 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 
• 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

Posted by Tim Sandle

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