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

GAO Accuses FDA of Tardy Trial Data

October 28, 2009

The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program.

New NIH Leader Backs Personalized Medicine

July 22, 2009

Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness research, he says, should identify subpopulation responses to treatment and support personalized medicine.

FDA Boosts Warnings on Propoxyphene Pain Meds

July 8, 2009

Pain medications containing propoxyphene could lead to overdose and death, according to new labeling mandated by FDA. However, public requests to take these drugs (including Darvon and Darvocet) off the market have been denied.

Are we moving towards global patenting?

July 1, 2009

Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling, using or importing the patented invention without the patent owner's permission. A theoretical ideal for an innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a decision is usually made as to where to file and process patent applications.

Sudden Deaths and ADHD Meds Not Necessarily Related

June 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

June 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

June 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."

Pharma Companies Hit With Warnings for Search Marketing

April 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?

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