PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter

FDA’s Oct. 24 public meeting on the renewal of its drug user fee program demonstrated just how strong a position the agency is in regarding the renewal of the Rx part of the “UFA” legislation – most of the complaints were semantic, quite literally.

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Business Background Of New CDER Director George Tidmarsh

 

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
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Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."