1 / 12

FDA Indecision

FDA Indecision. PDT. April 2003 Nasal Spray Draft Guidance. May 1, 2004 Weller Citizen Petition. August 31, 2005 FDA takes conflicting positions. February 21, 2006 FDA decides to apply PDT to all nasal sprays and Roslin passes. October 3, 2002 Roslin submits application.

vinny
Télécharger la présentation

FDA Indecision

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition August 31, 2005 FDA takes conflicting positions February 21, 2006FDA decides to apply PDT to all nasal sprays and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submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition October 2004FDA applies DMR and fails Roslin DMR

  2. FDA Indecision PDT 1999 Nasal Spray Draft Guidance DMR

  3. FDA Indecision PDT March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR

  4. FDA Indecision PDT PDT October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR

  5. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR

  6. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR

  7. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition DMR

  8. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition DMR

  9. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition October 2004FDA applies DMR and fails Roslin DMR

  10. FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition August 31, 2005 FDA takes conflicting positions October 3, 2002Roslin submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition October 2004FDA applies DMR and fails Roslin DMR

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

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

More Related