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Pharmaceutical

FDA publishes finalized guidance on medical apps

The FDA will not be regulating the majority of medical apps because they pose very little health risk to patients, but will instead adopt a "risk-based approach."
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FDA tightens grip on Indian drug makers

The U.S. Food and Drug Administration (FDA) has warned two Indian pharmaceutical companies over suspected breaches of good manufacturing practices.
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FDA reiterates warning over NuVision's sterile products

The U.S. Food and Drug Administration (FDA) has issued another alert over sterile products manufactured by Dallas-based NuVision Pharmacy.
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GlaxoSmithKline sets up $50 million fund to develop bioelectronic medicines

UK-based GlaxoSmithKline, one of the biggest pharmaceutical companies on the planet, wants to be a leader in the bioelectronic medicines space.
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Chinese pharma probe spreads to two Danish drug makers

Western pharmaceutical companies are coming under increased scrutiny in China following the bribery accusations leveled last month against GlaxoSmithKline (GSK).
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Generic drug patent settlements cut costs for health systems, study finds

The U.S. health system saved a total of $25.5 billion between 2005 and 2012 thanks to generic drugs being launched on the market before patent expirations as a result of patent settlements.
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FDA bans production at New Jersey compound firm over sterility issues

The U.S. Food and Drug Administration (FDA) has taken action against New Jersey-based compounding pharmacy Med Prep Consulting, Inc. over concerns relating to the sterility of its production.
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King Pharmaceuticals to pay $2.2 million over Clean Air Act violations

Tennessee-based King Pharmaceuticals, a subsidiary of Pfizer, Inc., will pay a $2.2. million penalty to resolve issues relating to allegations of Clean Air Act violations, the U.S. Environmental Protection Agency (EPA) announced.
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Chinese pharma industry eyes international opportunities

Big Chinese pharmaceutical companies are no longer happy playing only in their local markets. Several of them are hoping to establish a notable presence on the U.S. market, mostly through partnerships with international industry giants.
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U.S. pharmaceutical companies granted easier access to EU market

The United States is now considered a "listed country" by the European Commission, which means that U.S. companies don’t need an FDA export certificate before shipping certain pharmaceutical products to the European Union.
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