Most Clicked FDLI SmartBrief Stories
1. FDA releases draft guidance for biosimilars
FDLI SmartBrief | Feb 10, 2012
The FDA issued draft guidance for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs. Dr. Rachel Sherman, the FDA's associate director for medical policy, called the process "an abbreviated pathway that will depend on existing data." Bloomberg Businessweek (02/12) Reuters (02/09) Wall Street Journal, The (02/10)
2. FDA defends targeted surveillance of private email
FDLI SmartBrief | Feb 13, 2012
The FDA accessed the personal email accounts of certain employees in the agency's device-evaluation office to determine whether they inappropriately leaked confidential information to the public, according to spokeswoman Erica Jefferson. "Our targeted monitoring of email content of these individuals was not initiated" until after a company informed the FDA of a public disclosure in April 2010, Jefferson said. Washington Post, The (02/09)
3. FDA's proposed $4.5 billion budget heavily depends on industry fees
FDLI SmartBrief | Feb 14, 2012
The FDA asked for a $4.5 billion budget for fiscal 2013, up 17%, or $654 million, from this year. Industry user fees, including proposed fees for generics and biosimilars, would account for 45% of the budget and would fund 98% of the increase in spending. DOTMed.com (02/13) Reuters (02/13)
4. Enforcement transparency proposals are adopted by FDA
FDLI SmartBrief | Feb 15, 2012
The FDA has put in place the eight recommendations crafted by its transparency task force last year to improve access to compliance and enforcement data, including finding ways to use social media to boost communication with the public. The proposals were released for stakeholder comments in October of last year. Clinica (subscription required) (02/13)
5. Guidance from FDA advises heparin makers on safety
FDLI SmartBrief | Feb 13, 2012
The FDA issued guidance to drugmakers on how to better control heparin to prevent contamination. The posting comes four years after a contamination case resulted in deaths. Yahoo! (02/10)
6. EU regulator sets pharmacogenetic guideline for drugs
FDLI SmartBrief | Feb 14, 2012
The European Medicines Agency issued a guideline for drugmakers on how to take patients' genetic variability into consideration when assessing how the body reacts to drugs. The guideline on pharmacogenetic methodology in pharmacokinetic evaluation of treatments should be followed by all companies applying for marketing approval beginning Aug. 1, the agency said. PMLive.com (U.K.) (02/13) Pharma Letter (U.K.), The (subscription required) (02/12)
7. Senator wants to attach drug-shortage measure to highway bill
FDLI SmartBrief | Feb 15, 2012
Sen. Amy Klobuchar, D-Minn., plans to advance legislation to alleviate critical drug shortages by attaching it to a transportation bill the Senate is considering. "We acknowledge drug shortages may not have a lot to do with highways," Klobuchar said. "Maybe we have to try every bill, but we can't wait a year to get this done." Reuters (02/14)
8. Can Wacky Employee Perks Help You Retain Your Staff?
FDLI SmartBrief | Feb 13, 2012
OPEN Forum blogs (02/12)
9. U.S. charges former Takeda director with insider trading
FDLI SmartBrief | Feb 13, 2012
Brent Bankosky, a former Takeda Pharmaceutical director, partly settled an insider trading lawsuit with the Securities and Exchange Commission. Bankosky made $63,000 from call options ahead of Takeda's partnership with Cell Genesys and acquisition of Millennium Pharmaceuticals, the SEC said. Reuters (02/09)
10. 3 lawmakers worry about delayed reporting of trial data
FDLI SmartBrief | Feb 15, 2012
Three House Democrats sent letters to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins expressing concern about a BMJ report that drugmakers often do not publish findings of clinical drug trials in a timely manner. Delayed publication might "allow ineffective or dangerous drugs to remain on the market, resulting in significant harm to patients and waste in the health care system," they wrote. Hill, The (02/14)
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