Monday, December 24, 2012

FDA emphasizes compounding facilities need to be regulated | Essentials

Posted by

FDA emphasizes compounding facilities need to be regulated

FDA Works to Lessen Drug Shortage Impact
FDA Works to Lessen Drug Shortage Impact by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work
Excerpt:

SILVER SPRING, Md The head of the Food and Drug Administration renewed her push Wednesday for new laws to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest in cooperating with the agency. FDA Commissioner Margaret Hamburg met with state pharmacy regulators at a meeting to discuss the oversight of compounding pharmacies like the New England Compounding Center, the company which triggered a now 3-month-old outbreak of rare fungal meningitis. Contaminated injections from the Framingham, Mass. -based company have been blamed for 39 deaths and 620 illnesses, according to the Centers for Disease Control and Prevention. About 370 of the cases were caused by a rare form of fungal meningitis, which causes inflammation on the lining of the brain and spinal cord.

People:

Margaret Hamburg

Overall Sentiment: 0.115742

Relevance: 0.688496

SentimentQuote
0.0148815"We can do the most effective work when we do it in partnership," Hamburg told ...
0"We can do the most effective work when we do it in partnership," Hamburg told the heads of 50 state pharmacy boards, gathered at the FDA's headquarters. "This is a shared responsibility and the states are obviously on the front line of this issue."
0.093877Hamburg told reporters at the meeting she was "guardedly optimistic" ...
Sentiment Stats:
  • Number of Quotes: 3
  • Aggregate Sentiment: 0.1087585
  • Mean: 0.036252833333333
  • Standard Deviation: 1

Kathleen Sebelius

Overall Sentiment: 0.35539

Relevance: 0.291404

Rep. Fred Upton

Overall Sentiment: 0

Relevance: 0.288506

SentimentQuote
0"More than a month later, the FDA still has not produced its internal communications and documents related to NECC," said Rep. Fred Upton, ...
-0.438143"More than a month later, the FDA still has not produced its internal communications and documents related to NECC," said Rep. Fred Upton, R-Mich., who chairs the House Energy and Commerce Committee. "Without this information, we are unable to identify any possible weaknesses and as a result, the necessary corrections."
Sentiment Stats:
  • Number of Quotes: 2
  • Aggregate Sentiment: -0.438143
  • Mean: -0.2190715
  • Standard Deviation: 1.7320508075689
Disambiguation: Politician | U.S.CongresspersonReferences:

Dr. Benjamin Park

Overall Sentiment: -0.0670933

Relevance: 0.265191

Key:

  • Aggregate Sentiment is meant to be an indicator of an individual's overall sentiment.
  • The Mean is meant to be an indicator of an individual's average comment sentiment.
  • The Standard Deviation, when there are enough quotes, will indicate an individual's consistency of sentiment (i.e. a Standard Deviation of 0 would mean they were very consistent in their sentiment and 1 would mean they were very inconsistent).

Note that quote stats are likely to be meaningless beyond the aggregate score due to the tiny sample size. However, they are always provided just in case you find something useful there.

Additional Info:

HealthCondition: meningitis

Overall Sentiment: -0.154647

Relevance: 0.451252

City: SILVER SPRING

Overall Sentiment: 0

Relevance: 0.345556

StateOrCounty: Md

Overall Sentiment: 0

Relevance: 0.301592

PrintMedia: New England Journal of Medicine

Overall Sentiment: -0.135979

Relevance: 0.354475

Meta Tags Details
at
Labels: , , , ,

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)