Category Archives: Regulatory

Desperate Measures: Industry Teams with Parallel Traders to Tackle Counterfeiters in Europe

While action is heating up at the international level to tackle counterfeit drugs, Europe is making its own efforts to stop fake medicines from entering the legal supply chain. An improbable cross-sector partnership is struggling to secure support for a pan-European system to keep counterfeits out. It’s improbable because it brings together not only manufacturers, […]
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Social Media Questions Pharma Companies Should Be Asking

For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less. Social media poses a regulatory and litigation maze that must be carefully navigated. Here, Mathew dos Santos and Lori Leskin provide some insight into the most pressing questions companies are, […]
Also posted in E-Media, FDA, Guest Blog, multimedia, Patient Communication, social media | Tagged , , | Leave a comment

US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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Bureaucratic Roadblocks Threaten Biopharma Growth

Ahead of the BIO International Convention next week, Jim Greenwood, President and CEO of the Biotechnology Industry Organization, writes that protecting intellectual property rights is vital to biopharma innovation. There is a clear link between a country’s rate of economic development and the strength of its intellectual property laws. This is particularly true in knowledge-intensive […]
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EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
Also posted in Europe, Global, Safety | Tagged , , , , , | Leave a comment
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