Terrifying Budget Numbers

Friday, September 22, 2006

For all that consumers expect from the U.S. Food and Drug Administration, it is completely irresponsible of the federal government to fund it with less than $2 billion a year. By comparison, that’s exactly the same dollars the federal government is spending each week on the war in Iraq.

[Read More]

Medical Device CROs Setting Up Shop in Emerging Markets

Wednesday, September 20, 2006

Alquest, a medical device focused contract research organization (CRO) based in Minneapolis, Minn., has launched services in India. The company claims to be the first such CRO to expand medical device offerings into the emerging India trials market. Medical device companies are particularly afflicted by challenging patient recruitment rates, and Alquest feels many companies will head to India to shave costs.

[Read More]

Fighting The Logjam In LatAm Drug Trials

Monday, September 18, 2006

Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.

[Read More]

FDA Offers Guidance on Informed Consent Exemptions

Wednesday, September 13, 2006

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It’s a big issue. Informed consent is a ‘sacred cow’ in today’s clinical trial industry, and rightly so.

[Read More]

Former Head of German CRO IMFORM Sentenced for Fraud, Corruption

Monday, September 11, 2006

Peter U. Witte, former president and chief executive officer of IMFORM, a contract research organization (CRO) based in Darmstadt, Germany, was sentenced in August to four years in jail in Munich District Court for fraud, corruption, and aiding and abetting the betrayal of confidence. CW Weekly has been investigating what led up to Witte’s sentencing for several months. Witte confessed that for years he had defrauded his principal client, Japan-based pharmaceutical company Sankyo, with bills for several million euros for services supposedly performed during a drug study, according to a published report in Süddeutsche Zeitung.

[Read More]

Disapproving Look

Tuesday, September 5, 2006

Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.

[Read More]