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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 April 2003 Nasal Spray Draft Guidance.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.

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FDA Indecision

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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition August 31, 2005 FDA takes conflicting positions February 21, 2006FDA decides to apply PDT to all nasal sprays and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submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition October 2004FDA applies DMR and fails Roslin DMR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 FDA Indecision PDT 1999 Nasal Spray Draft Guidance DMR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 FDA Indecision PDT March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR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Indecision PDT PDT October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance DMR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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition DMR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 FDA Indecision PDT April 2003 Nasal Spray Draft Guidance May 1, 2004Weller Citizen Petition October 3, 2002Roslin submits application July 26, 2004Weller Citizen Petition March 2000 Roslin asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004GKE Citizen Petition DMR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

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