Trusted Collaboration

Outsourcing different aspects of the clinical study process is a growing trend; 64 percent of trials are currently outsourced. Of those that don’t currently, 54 percent plan to outsource in the future*. Sponsors outsource to clinical research organizations (CROs) to control operational and infrastructure costs and allow them to concentrate on what they do best – drug development.
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Inconsistent Labeling on Grapefruit Juice-Drug Interactions May Cause Harm


Consider this: A patient arrives at the emergency room, heart rate slowing and blood pressure falling. Doctors are aware that the patient is taking a blood pressure drug to prevent migraine headaches, but blood tests reveal an alarmingly high level of the drug in the patient’s system. They suspect an accidental overdose, until it is discovered that the patient is a fan of grapefruit juice, a food that can interact with drugs and increase the risk of potentially dangerous situations.
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Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs


The Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) have ramped up their prosecution of corporations and officers for violations of the Foreign Corrupt Practices Act (FCPA). From 2010 to 2013, the DOJ and the SEC brought a combined 172 FCPA-related actions, for an average of 43 each year. There has been an added focus on pharmaceutical and medical device companies, resulting in significant FCPA settlements like those of Johnson & Johnson in 2011, Smith & Nephew and Biomet in 2012, and Stryker in 2013. Many more companies have either disclosed or are reportedly involved in ongoing FCPA investigations, including AstraZeneca, Bristol-Myers Squibb, Cubist Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Grifols SA, Merck, Nordion, Novartis AG, Sanfoni SA, Sciclone Pharmaceuticals, and Teva Pharmaceutical.
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EQMS: An Rx for Ensuring Quality in Over-the-Counter Drugs


The pharmaceutical industry faces complex challenges resulting from regulatory scrutiny, mergers and acquisitions, and a myriad of cost-cutting requirements. Like all pharmaceutical manufacturers, nonprescription drug makers – whose products are readily available over-the-counter (OTC) by most consumers – have a responsibility to ensure the drugs being stocked on store shelves are safe, effective and properly labeled.
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8 Checkpoints for Managing Government Pricing During Mergers & Acquisitions


The pharmaceutical industry is going through a period of unprecedented merger and acquisition (M&A) activity. While pharmaceutical companies must remain focused on the big picture, they also must manage the specific details of M&As — including a wave of legal, financial, and strategic alignment issues and the required due diligence needed to identify and resolve compliance risks related to government pricing (GP).
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Drugs on Tap: Managing Pharmaceuticals in Our Nation’s Waters


Pharmaceutical pollutants plague our environment. They are found in rivers and lakes, groundwater and soils, and even in public drinking water supplies. Some studies suggest unintended exposure to these pollutants may adversely affect human health; other research more conclusively shows that even minute concentrations can detrimentally affect aquatic species.
 
Federal and state governments have made little effort to develop broad strategies to address the consequences of exposure to pharmaceutical pollutants. Our environmental and water-related laws and regulations are ill-equipped to respond to this growing threat. Moreover, treating out these pernicious substances is too costly for most municipalities and water treatment operators.
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