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NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional...

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NDA at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement
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Page 1: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

NDA at the FDA

Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement

Page 2: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

2

Agenda

• Before NDA : Brief overview of the drug development

• NDA at FDA: terminology and timelines

• NDA at FDA: review conduct

• Post NDA review

• approval data • public information

Page 3: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

3

https://www.youtube.com/watch?v=JVNDgfCT1pg

Drug Development

Page 4: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

Timeline of Drug Development

Pre-clinical

Phase 1

Phase 3

Phase 4

Phase 2

post- approval pre-IND IND NDA

NDA Review

3-6 years 6-7 years 1 year >>> years

Page 5: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

NDA at FDA Designations and Reviews

• Fast Track*

• Orphan Drug • Breakthrough*

• Standard • Priority* • Rolling

Accelerated Approval*

* types of expedited programs 5

Page 6: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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NDA Review Timeline

Page 7: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Agenda

• Before NDA: Brief overview of the drug development

• NDA at FDA: terminology and timelines

• NDA at FDA: review conduct

• Post NDA review

• approval data • public information

Page 8: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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NDA Review Clinical

Statistics

Pharmacology

Chemistry

Toxicology

Labeling

Consults: PRO, OC, QT, DRISK, DMEPA, OPDP, PeRC, PREA, CDRH

Page 9: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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NDA Review Benefit-Risk Framework

Benefit

Risk

Page 10: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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NDA Review Decision

EXTENSION

Page 11: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Approval

o drug name o labeling o promotional material o manufacturing facilities

Page 12: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Agenda

• Brief overview of the drug development

• NDA at FDA: terminology and timelines

• NDA at FDA: review conduct

• NDA post FDA review:

• more data • approval data • public review information

Page 13: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

Post NDA Review

• FDA asks for more data • Company expends development program • Company/FDA follow drug safety

13

Page 14: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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NDA/BLA Approval Data

34

84

37

84

24

70

0

10

20

30

40

50

60

70

80

90

Priority (8 months) Standard (12 months)

Num

ber o

f App

rova

ls

2014 2015 2016

CDER approvals database

Page 15: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Overall Median Time to Approval

8.1

10.9

7.8

0

2

4

6

8

10

12

2014 2015 2016

Mon

ths

Page 16: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Global Drug Approvals New Active Substances -First Launches by Region 2001 – 2015

Page 17: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

NDA post-APPROVAL

• Press release • FDA reviews and Prescribing Information

(Drugs@FDA) • Drug Trial Snapshots

17

Public review information

Page 18: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Accessing FDA Reviews

Page 19: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Accessing FDA Reviews

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Page 21: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Page 22: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

Who Participated in the Clinical Trials?

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Page 23: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

Content of a Snapshot

• Information about who participated in the clinical trials

and • Information about

– trial design – overall drug efficacy and safety – differences in efficacy and safety among sex, race,

and age subgroups

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Page 24: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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Reviews PI DTS

Complexity and length of the document

Comprehensive drug information

Rationale for approval

Demographics in drug development program

Demographics in pivotal trials/subgroups

Reasons for specific subgroup representation

Consumer friendly information

Public Info Comparison

Page 25: NDA at the FDA - U S Food and Drug Administration … at the FDA Milena Lolic, MD, MS Professional Affairs and Stakeholder Engagement 2 Agenda • Before NDA : Brief overview of the

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