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

Sudden Deaths and ADHD Meds Not Necessarily Related

Jun 17, 2009

Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount to pulling kids off of ADHD treatments.

WHO Pushes H1N1 Flu to Pandemic State

Jun 11, 2009

The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years.

FDA Launches Transparency Task Force

Jun 3, 2009

The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed.

FDA Releases Guidance on Risk in Ads

May 27, 2009

You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."

How to Fix FDA

May 1, 2009

A five-step blueprint for building a new federal drug and device regulatory agency.

Pharma Companies Hit With Warnings for Search Marketing

Apr 8, 2009

FDA is cracking down on content in search engine advertisements. The argument is that there is a serious deficiency of risk information in the tiny link ads that appear on search ads. With pharma already wary of marketing online, will FDA’s tactic hurt future Web campaigns?

FDA Demands Pharma Firms Pull Unapproved Drugs

Apr 1, 2009

The Feds are on the warpath, cracking down on pharmaceutical companies that manufacture and market unapproved prescription narcotics.

Comparative Effectiveness Research: Coming Soon?

Mar 24, 2009

Only time will reveal CER's true definition, and determine the full effects of a CER-based system

Massachusetts Passes New Sales and Marketing Rules

Mar 18, 2009

The latest state-level attempt to regulate pharma marketing is also the most stringent, requiring both drug and device manufacturers to track and disclose marketing spend. And the state's very important biotech industry is crying foul.

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