interacting with fda - rare disease · pdf filepharmacology reviewer chemistry, manufacturing...

1

Interacting with FDA

R. Wes IshiharaChief, Project Management Staff

Division of Gastroenterology Products

2

Overview• Structures

– Organizational– Team Dynamics– Statutory and Regulatory

• Processes– Pre-IND Submission Activities– IND Submission and Review– Post-Submission Activities and

Responsibilities

3

Structures

• Organizational• Team Dynamics• Statutory and Regulatory

4

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

5

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

6

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

7

Structures


8

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

9


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

10


Animal Pharmacology/Toxicology

Chemistry, Manufacturing and Controls

Clinical Pharmacology

Statistics

**others**

Clinical

Rev

iew

Issu

es

11


Statistical Reviewer

MedicalOfficer

ClinicalPharmacology

Reviewer

PharmacologyReviewer

CMCReviewer

Medical TL

RPMCommunications w/ Sponsors:E.g., Information Request

Scientific/RegulatoryRecommendationsto Signatory Authority

12

Structures


13

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

14

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

15

Process: What you can expect

• Pre-IND Submission Activities• IND Submission and Review• Post-Submission Activities and

Responsibilities

16

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

17

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

18



Responsibilities

19

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

20


• 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

21


• 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”

22



Responsibilities

23

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

interacting with fda - rare disease · pdf filepharmacology reviewer chemistry, manufacturing...

Documents