Transcript Animation

FDA Indecision
PDT
August 31, 2005
February 21, 2006
FDA takes conflicting positions
FDA decides to apply PDT to all
nasal sprays and Roslin passes
October 2004
FDA applies
DMR and fails
Roslin
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
1
FDA Indecision
PDT
1999
Nasal Spray
Draft Guidance
DMR
2
FDA Indecision
PDT
1999
Nasal Spray
Draft Guidance
March 2000
Roslin asks
for “goalposts”
DMR
3
FDA Indecision
PDT
October 3, 2002
Roslin submits application
1999
Nasal Spray
Draft Guidance
March 2000
Roslin asks
for “goalposts”
DMR
4
FDA Indecision
PDT
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
1999
Nasal Spray
Draft Guidance
March 2000
Roslin asks
for “goalposts”
DMR
5
FDA Indecision
PDT
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
1999
Nasal Spray
Draft Guidance
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
6
FDA Indecision
PDT
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
7
FDA Indecision
PDT
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
8
FDA Indecision
PDT
October 2004
FDA applies
DMR and fails
Roslin
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
9
FDA Indecision
PDT
August 31, 2005
FDA takes conflicting positions
October 2004
FDA applies
DMR and fails
Roslin
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
10
FDA Indecision
PDT
August 31, 2005
February 21, 2006
FDA takes conflicting positions
FDA decides to apply PDT to all
nasal sprays and Roslin passes
October 2004
FDA applies
DMR and fails
Roslin
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
11
FDA Indecision
PDT
August 31, 2005
February 21, 2006
FDA takes conflicting positions
FDA decides to apply PDT to all
nasal sprays and Roslin passes
October 2004
FDA applies
DMR and fails
Roslin
April 2003
Nasal Spray
Draft Guidance
October 3, 2002
Roslin submits application
May 19, 2004
1999
GKE Citizen Petition
Nasal Spray
Draft Guidance
July 26, 2004
Weller Citizen
Petition
March 2000
Roslin asks
for “goalposts”
May 1, 2004
Weller Citizen
Petition
DMR
12