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FDA Indecision

FDA Indecision. PBE. 1999 Nasal Spray Draft Guidance. GMR. FDA Indecision. PBE. March 2000 Ronald asks for “goalposts”. 1999 Nasal Spray Draft Guidance. GMR. FDA Indecision. PBE. PBE. October 3, 2002 Ronald submits application. March 2000 Ronald asks for “goalposts”.

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FDA Indecision

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  1. FDA Indecision PBE 1999 Nasal Spray Draft Guidance GMR

  2. FDA Indecision PBE March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance GMR

  3. FDA Indecision PBE PBE October 3, 2002Ronald submits application March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance GMR

  4. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance October 3, 2002Ronald submits application March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance GMR

  5. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warren Citizen Petition October 3, 2002Ronald submits application March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance GMR

  6. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warren Citizen Petition October 3, 2002Ronald submits application March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004Citizen Petition GMR

  7. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warner Citizen Petition October 3, 2002Ronald submits application July 26, 2004 Warner Citizen Petition March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004Citizen Petition GMR

  8. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warren Citizen Petition October 3, 2002Ronald submits application July 26, 2004Warren Citizen Petition March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004Citizen Petition October 2004FDA applies GMR and fails Ronald GMR

  9. FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warren Citizen Petition August 31, 2005 FDA takes conflicting positions October 3, 2002Ronald submits application July 26, 2004Warren Citizen Petition March 2000 Ronald asks for “goalposts” 1999 Nasal Spray Draft Guidance May 19, 2004Citizen Petition October 2004FDA applies GMR and fails Ronald GMR

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 FDA Indecision PBE April 2003 Nasal Spray Draft Guidance May 1, 2004Warren Citizen Petition August 31, 2005 FDA takes conflicting positions February 21, 2006FDA decides to apply PBE to all nasal sprays and Ronald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

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

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