Regulatory News - Pharmaceutical Executive

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Regulatory News
New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

EU Probes Pharma

December 3, 2008

Last January, the EU raided pharma companies searching for evidence of anti-trust violations. The newly issued report on the incident comes down hard on industry for what look like normal patent-protection activities. Could the same thing happen in the US?

OTC Viagra Not Ready For Prime Time

November 26, 2008

Pfizer decided to pull back its application for an over-the-counter version of its blockbuster ED drug after the release of a report stating that the ease of availability could lead to misuse of the drug.

Feds in Hot Water for No-Bid PR Contract

November 19, 2008

Things heat up in Washington as FDA is called to task for a controversial contracts deal with a local public relations firm. Both the Senate and the House are looking for answers, and the feds no longer have a PR firm to run damage control.

FDA Pulls Amgen Brochure for Misleading Language

November 5, 2008

Colorful and cheerful aren’t always a good thing; an illustrated brochure for Amgen’s Sensipar gets canned by FDA for too thin a listing of side effects and adverse reaction data.

Wyeth v. Levine Takes Center Stage

November 5, 2008

Wyeth v. Levine was argued before the US Supreme Court on Monday. With the justices asking aggressive questions of both sides, the verdict remains very much in doubt. All eyes are on Washington.

Chantix, Heparin Top List of Adverse Events

October 29, 2008

A new study finds that side-effect reports are on the rise, with Chantix and heparin topping the list. Are popular drugs getting a bad rap because they're in the headlines? Or are people just reporting more side effects?

Shire Receives Warning For YouTube Video

October 8, 2008

Shire received a warning letter from FDA citing failure to provide warnings in non-traditional consumer ads. Is it time to look at better regulations for new media? Worse yet, is FDA watching YouTube?

Prasugrel Decision Delayed; No Reason Why

October 1, 2008

Lilly's coronary drug still hasn't been approved. FDA is mum on what?s taking so long, and analysts are left pondering the status of the medication.

Purepac Preemption Defense Denied

October 1, 2008

Just a few weeks from the start of the mammoth Wyeth v. Levine Supreme Court hearing, a small state case hammered home the fact that generic drug manufacturers can't expect preemption to save them just because FDA approved the label.

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