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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

The FDA Law Blog

However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. If a drug is approved, section 916 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (codified at 21 U.S.C. §

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CDC Report Finds No Connection Between Thimerosal and Autism

Drug Topics

The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines. Thimerosal is a mercury-containing compound that has been widely used as a preservative in some biological and drug products since the 1930s. Hinrichsen, V. Eriksen, E.,

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The European Market Access Lag: 2021–2024

Pharmaceutical Technology

For example, Recordati’s Cystadane (betaine) was centrally approved in 2007 but did not see its first reimbursement in Poland until 2023. In Romania, Novartis’s Atriance (nelarabine) was also centrally approved in 2007 but did not receive its first reimbursement in Romania until 2021.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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7 Best DRY MOUTH lozenges for saliva production

Druggist

HAp+ Dry Mouth Drops - 16 Strawberry & Rhubarb Flavoured Lozenges - Mouth Watering, Vegan, and Sugar Free - Maintains Healthy Teeth - Blister Pack - New Packaging (Strawberry & Rhubarb). Ship JA, McCutcheon JA, Spivakovsky S, Kerr AR (2007). 2007 Oct;34(10):724-32. 5,061 Reviews. £4.95. J Oral Rehabil.

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Purdue to pay $8.3bn after admitting criminal charges in opioid case

pharmaphorum

Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits. It admitted to bribing two doctors to write more prescriptions of OxyContin as well as other drugs between June 2009 and March 2017. Image by Gerd Altmann from Pixabay.

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Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015 and led corporate strategy for Celgene from 2007 to 2010 ( see more on LinkedIn ). This brings us to VivoSense.