Labeling Changes For Products In Strategic National Stockpile To Be Controlled By FDA, Not Firms
This article was originally published in The Pink Sheet Daily
Final rule allows CDC officials to request waivers or alternatives to labeling of certain medical products in a national emergency. Industry had wanted to narrow the waiver powers; hospitals had wanted to broaden them. FDA declined to do either.
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House- and Senate-passed bills reauthorizing the 2006 Pandemic and All-Hazards Preparedness Act are similar in many respects in their efforts to accelerate medical countermeasure development. However, the House bill lacks a Senate provision that would allow HHS to contract with a non-profit entity to invest in companies developing countermeasures.
Uncle Sam's Orders: Emergent Scores $107 Mil. For Anthrax Plant, While Bavarian Nordic Delivers On Smallpox
Government funding for the BioThrax plant suggests there are doubts other new treatments will be ready soon. But funding for the BioShield program may be reduced during congressional debate on appropriations.
Avian influenza vaccine will not be commercially available but will be included in the national stockpile, FDA says.