Showing posts with label clean rooms. Show all posts
Showing posts with label clean rooms. Show all posts

Friday, December 21, 2012

Mass. Firm Tied to Closed Pharmacy Issues Recall | Reduction

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Mass. Firm Tied to Closed Pharmacy Issues Recall

FDA Drug Shortages Briefing (3151)
FDA Drug Shortages Briefing (3151) by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work
Excerpt:

A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it's recalling all its products after federal inspectors said it must improve its sterility testing process. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose. She would only say: "We found there was not adequate assurance of sterility in their sterile products." Woodcock stressed the agency knows of no infections linked to the recalled products. In a statement, Westborough-based Ameridose said it issued the recall "out of an abundance of caution." "Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said.

People:

Dr. Janet Woodcock

Overall Sentiment: -0.187356

Relevance: 0.943032

Barry Cadden

Overall Sentiment: -0.269247

Relevance: 0.605163

Stephen Runge

Overall Sentiment: 0.0670072

Relevance: 0.484885

SentimentQuote
0.0549486"Their marketing material is baloney. They are just saying what they want to say," said Stephen Runge, ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0.0549486
  • Mean: 0.0549486
  • Standard Deviation: 1.4142135623731

Greg Conigliaro

Overall Sentiment: 0

Relevance: 0.412002

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:

PrintMedia: The Boston Globe

Overall Sentiment: 0.0118451

Relevance: 0.577879

Disambiguation: AwardPresentingOrganization | AwardWinner | Company | NewspaperReferences:

HealthCondition: meningitis

Overall Sentiment: -0.666327

Relevance: 0.71315

Organization: U.S. Food and Drug Administration

Overall Sentiment: 0.158236

Relevance: 0.964425

Organization: Center for Drug Evaluation and Research

Overall Sentiment: 0

Relevance: 0.523234

Organization: FDA

Overall Sentiment: 0

Relevance: 0.503827

Company: nanoCLEAN Decontamination Services

Overall Sentiment: 0.0273224

Relevance: 0.494606

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Saturday, December 15, 2012

Pharmacy head pleads Fifth at meningitis outbreak hearing | Essentials

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Pharmacy head pleads Fifth at meningitis outbreak hearing

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:

WASHINGTON Barry Cadden, the owner and director of the specialty pharmacy connected to fatal fungal meningitis episode decreased to testify Wednesday morning prior to a congressional committee examining the matter. Cadden, co-founder of the New England Compound Center, informed legislators he would utilize his Fifth Amendment right to not answer questions in order to prevent self-incrimination. Congressional hearing to be held on meningitis episode After duplicated questioning by House legislators, Cadden informed your home Energy and Commerce Committee: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment.". Lawmakers continued to ask Cadden questions about the contamination of steroids made use of to deal with patients -- lots of for back discomfort -- that has actually sickened almost 430 people with fungal meningitis and triggered 32 deaths. An additional 10 patients have peripheral joint infections from treatments.

People:

Barry Cadden

Overall Sentiment: -0.011741

Relevance: 0.732307

SentimentQuote
0.0386955Cadden told the House Energy and Commerce Committee: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0.0386955
  • Mean: 0.0386955
  • Standard Deviation: 1.4142135623731

Margaret Hamburg

Overall Sentiment: 0

Relevance: 0.450779

SentimentQuote
-0.0521291"FDA's authority over compounding pharmacies is limited by law and is not suited to effectively regulate the evolving compounding industry," Hamburg said, ...
0"FDA's authority over compounding pharmacies is limited by law and is not suited to effectively regulate the evolving compounding industry," Hamburg said, in a statement released ahead of the hearing in D.C.. "We need a clear path forward that is proactive and preventive."
-0.111531"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," Hamburg states ...
Sentiment Stats:
  • Number of Quotes: 3
  • Aggregate Sentiment: -0.1636601
  • Mean: -0.054553366666667
  • Standard Deviation: 1.4142135623731
Disambiguation: U.S.Congressperson | PoliticianReferences:

Joyce Lovelace

Overall Sentiment: 0

Relevance: 0.323814

Eddie C. Lovelace

Overall Sentiment: -0.123334

Relevance: 0.30951

Greg Conigliaro

Overall Sentiment: -0.332478

Relevance: 0.297823

Laura Strickler

Overall Sentiment: 0

Relevance: 0.296667

Jim Axelrod

Overall Sentiment: 0

Relevance: 0.284169

Rep. Cliff Stearns, R-Fla.

Overall Sentiment: -0.058635

Relevance: 0.258988

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:

StateOrCounty: Mass.

Overall Sentiment: -0.147627

Relevance: 0.335187

Disambiguation: Location | PoliticalDistrict | AdministrativeDivision | GovernmentalJurisdiction | USStateReferences:

StateOrCounty: Kentucky

Overall Sentiment: -0.12534

Relevance: 0.30624

Disambiguation: Location | PoliticalDistrict | AdministrativeDivision | GovernmentalJurisdiction | USStateReferences:

TelevisionShow: CBS Evening News

Overall Sentiment: 0

Relevance: 0.318202

TelevisionStation: CBS News

Overall Sentiment: 0

Relevance: 0.317768

Organization: Food and Drug Administration

Overall Sentiment: -0.0310133

Relevance: 0.655245

Organization: Congress

Overall Sentiment: 0.0492668

Relevance: 0.469371

Disambiguation: Dedicator | GovernmentalBody | Legislature | NaturalOrCulturalPreservationAgencyReferences:

Organization: congressional committee

Overall Sentiment: -0.395181

Relevance: 0.356576

Organization: New England Compound Center

Overall Sentiment: 0

Relevance: 0.349239

Organization: Commerce Committee

Overall Sentiment: -0.354936

Relevance: 0.342872

Organization: House

Overall Sentiment: 0

Relevance: 0.339203

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