Tag Archives: regulatory affairs

"Sunshine" Just the Tip of the Iceberg: Pharma and Full Disclosure

“Sunshine” Just the Tip of the Iceberg: Full Disclosure for Pharma:??There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices, writes Jill Wechsler. Although recent legislation and regulations have greatly expanded the range of information that pharmaceutical companies have to unveil to the public, there’s an escalating [...]
Posted in Guest Blog, Op-Ed, Regulatory, Safety, Strategy, healthcare, pricing | Also tagged , , , | 1 Comment

Paul Ryan and Pharma: The Inside Story

by Tom Norton Well, we certainly have a presidential campaign now, don’t we? Good grief. Since Rep. Paul Ryan was named the Republican VP candidate last week, all hell has broken loose!  Given the intensity of the last few days, you’d think the election was tomorrow… And at some point, you do have to ask yourself, “Really, [...]
Posted in FDA, Guest Blog, Op-Ed, healthcare | Also tagged , , , , | 3 Comments

Regulator Move Re-Opens Arguments over European Transparency

At the end of last month, European public health and transparency campaigners sent a letter to EC health commissioner John Dalli, outlining their concerns about former EMA head Thomas Lönngren’s recent career move. The Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) — and [...]
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US Mid-Term Elections: What It Means for Pharma

Daily News Nugget US Mid-Term Elections:  What it Means for Pharma Drink up, even if it’s  only old wine in new bottles… Yesterday’s mid-term congressional poll barely changes the stakes for pharma in its pursuit of its US legislative and regulatory agenda.    The key message coming out of the results is stalemate on the big issues like [...]
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And What Exactly is a Stakeholder?

Pharma’s uncritical use of the word ‘stakeholder’ has increased to the point where it can refer to almost anyone connected to the industry. But this can have serious consequences, warns Reflector. Like it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to [...]
Posted in Europe, Global, Guest Blog, Regulatory | Also tagged , , , , , , , | 1 Comment