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
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
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 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
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
• 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
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 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
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
• 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
• 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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