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Transcript of Interacting with FDA - Rare disease · PDF filePharmacology Reviewer Chemistry, Manufacturing...
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Interacting with FDA
R. Wes IshiharaChief, Project Management Staff
Division of Gastroenterology Products
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Overview• Structures
– Organizational– Team Dynamics– Statutory and Regulatory
• Processes– Pre-IND Submission Activities– IND Submission and Review– Post-Submission Activities and
Responsibilities
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Structures
• Organizational• Team Dynamics• Statutory and Regulatory
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Structures: Organizational (1)Center for
Drug Evaluationand Research
Office ofNew Drugs
Office ofPharmaceutical
Science
Office ofTranslational
Sciences
**there areothers**
Office ofNew Drug
QualityAssessment
Office ofBiotechnology
Products
Office ofBiostatistics
Office ofClinical
Pharmacology
3 QualityDivisions
Division ofTherapeutic
Proteins
7 BiometricDivisions
6 ClinicalPharmacology
Divisions
6 “ReviewOffices”
18 “ReviewDivisions”
**there areothers**
Division ofMonoclonalAntibodies
Note: This is a simplified organizational chart for presentation purposes and does not reflect all Offices/Division within CDER
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Structure: Organizational (2)Office of
New Drugs
Office ofDrug Evaluation I
Office ofDrug Evaluation II
Office ofDrug Evaluation III
Office ofDrug Evaluation IV
Office ofAntimicrobial
Products
Office ofOncology
Drug Products
Division ofCardiovascular
and RenalProducts
Division ofNeurologyProducts
Division ofPsychiatryProducts
Division ofAnesthesia,
Analgesia, andRheumatology
Products
Division ofMetabolism andEndocrinology
Products
Division ofPulmonary and
AllergyProducts
Division ofGastroenterology
Products
Division ofDermatology andDental Products
Division ofReproductiveand Urologic
Products
Division ofNonprescription
RegulationDevelopment
Division ofNonprescription
ClinicalEvaluation
Division ofMedical Imaging
Products
Division ofAnti-Infective and
OpthalmologyProducts
Division ofAntiviralProducts
Division ofSpecial Pathogen
and TransplantProducts
Division ofDrug Oncology
Products
Division ofHematology
Products
Division ofBiologic Oncology
Products
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Structures: Organizational (3)CDER
Office of New Drugs
Office of Pharmaceutical
Science
Office ofTranslational
Sciences**others**
Medical TL*(“Cross Discipline TL”)
Pharmacology Reviewerand TL
CMC* Reviewer and TL Clinical Pharmacology
Reviewer and TL
Statistics Reviewerand TL
Medical Officer**others**
Regulatory HealthProject Manager Review Team
*CMC = Chemistry, Manufacturing and Controls*TL = Team Leader
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Structures
• Organizational• Team Dynamics• Statutory and Regulatory
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Structures: Team Dynamics (1)
Medical Team Leader(“Cross Discipline TL”)
Pharmacology Reviewer
Chemistry, Manufacturingand Controls Reviewer
Clinical PharmacologyReviewer
Statistics Reviewer
Medical Officer
Regulatory HealthProject Manager = BSN, MSN, PharmD, RPh, MS, MPH, BS
= MD, PhD, MPH
= MD, PhD, MPH
= PhD, MS
= PhD, PharmD
= PhD
= PhD, MS
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Structures: Team Dynamics (2)
Statistical Reviewer
& TL
MedicalOfficer
ClinicalPharmacology
Reviewer& TL
PharmacologyReviewer
& TL
CMCReviewer
& TL
Medical TL
RPM*
Incoming Submissions:INDs, NDAs, BLAs, Meeting Requests, Written Inquiries, etc.
Inquiries fromSponsors
*RPM = Regulatory Health Project Manager
DocumentRoom
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Structures: Team Dynamics (3)
Animal Pharmacology/Toxicology
Chemistry, Manufacturing and Controls
Clinical Pharmacology
Statistics
**others**
Clinical
Rev
iew
Issu
es
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Structures: Team Dynamics (4)
Statistical Reviewer
MedicalOfficer
ClinicalPharmacology
Reviewer
PharmacologyReviewer
CMCReviewer
Medical TL
RPMCommunications w/ Sponsors:E.g., Information Request
Scientific/RegulatoryRecommendationsto Signatory Authority
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Structures
• Organizational• Team Dynamics• Statutory and Regulatory
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Structures: Statutory/Regulatory (1)
Food, Drug, and Cosmetic Act /Public Health Service Act
Code of Federal Regulations(21 CFR)
Guidances
Policy and Procedures(MaPPs)
Search: “CFR” @ www.FDA.gov
Search: “Guidances” @ www.FDA.gov
Search: “Manual of Policies and Procedures” @ www.FDA.gov
An Act of Congress
Search: “legislation” @ www.FDA.gov
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Structures: Statutory/Regulatory (2)
Investigational New Drug Application (IND)• 21 CFR Part 312New Drug Application (NDA)• 21 CFR Part 314Biologics Licensing Application (BLA)• 21 CFR 600’s
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Process: What you can expect
• Pre-IND Submission Activities• IND Submission and Review• Post-Submission Activities and
Responsibilities
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Process: Pre-IND Submission Activities
• Pre-IND Meeting– Guidance for Industry: Formal Meetings
Between the FDA and Sponsors or Applicants
• Search: “Formal Meetings” @ www.FDA.gov– Tracked Timeframe: Type B
• Meeting date: ~60 days from date of request• Formal meeting request required• Background package: due to FDA 4 weeks prior
to meeting date– Pre-IND file created
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Process: Pre-IND Submission Activities
• Other Formal Meetings to Plan For:– Certain End-of-Phase 1 Meetings (Type B)– End-of-Phase 2 Meetings (Type B)– Pre-NDA/Pre-BLA Meetings (Type B)– Others (Type C)
• Other Correspondence
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Process: What you can expect
• Pre-IND Submission Activities• IND Submission and Review• Post-Submission Activities and
Responsibilities
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Process: IND Submission/Review (1)
• IND Content and Format (21 CFR 312.23)
• Notify FDA• Submit one original and two copies to:
Food and Drug AdministrationCenter for Drug Evaluation and ResearchDivision of ____________5901-B Ammendale RoadBeltsville, MD 20705-1266
Food and Drug AdministrationCenter for Biologics Evaluation and ResearchHFM-99, Room 200N1401 Rockville PikeRockville, MD 20852-1448
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Process: IND Submission/Review (2)
• 30-day review “clock”– RPM will generally communicate the “30-
day review date”• Reviewers are assigned upon receipt
– Document Room processing time• Studies can not start until 30-days
following FDA receipt of a new IND
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Process: IND Submission/Review (3)
• Frequency and timing of communications between sponsor and FDA
• Clinical holds – Defined by 21 CFR 312.42– Teleconferences: be available to discuss
potential hold issues– “Complete Response to Clinical Hold”
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Process: What you can expect
• Pre-IND Submission Activities• IND Submission and Review• Post-Submission Activities and
Responsibilities
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Process: Post-Submission
• Safety reporting– 21 CFR 312.32
• Annual reports– 21 CFR 312.33
• IND withdrawal– 21 CFR 312.38
• Other Responsibilities– 21 CFR 312.50 through 312.70
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