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Most Clicked FDLI SmartBrief Stories


1. FDA to launch fellowships to recruit younger staffers

FDLI SmartBrief | Jul 21, 2008

The FDA announced a two-year fellowship program to attract physicians, chemists, statisticians and other science professionals to the agency, to help replace the hundreds of scientists who are retiring. About 30 to 40 people will be accepted for the first program, set to start in October, with some of the fellows expected to stay on as full-time FDA employees after they finish the program. CNNMoney.com (07/18)


2. FDA to exempt early-stage drugs from GMP regulations

FDLI SmartBrief | Jul 17, 2008

The FDA has released a final rule that would exempt experimental drugs in Phase I development from some good manufacturing practice regulations. The rule, which is set to take effect Sept. 15, will apply to small-molecule treatments and biotech drugs such as vaccines and gene-therapy products. FDAnews (07/16)


3. Senate committee clears $2B in funding for FDA

FDLI SmartBrief | Jul 21, 2008

The Senate Appropriations Committee on Thursday unanimously approved a bill that would provide the FDA with a $2.04 billion budget for fiscal 2009. The agriculture subcommittee passed the measure on June 19. The agency "is a firewall for our citizens" and should not be allowed to fail, said Sen. Herb Kohl, D-Wis. FDAnews (07/21)


4. Study: Low-carb diet promotes more weight loss

FDLI SmartBrief | Jul 17, 2008

Individuals who followed a diet low in carbohydrates lost more weight and improved their cholesterol more than those who followed a low-fat diet, a new study shows. A representative from the Dr. Robert C. and Veronica Atkins Foundation called the study a "vindication." Yahoo! (07/17)


5. States to split about $400M from Bristol-Myers settlement

FDLI SmartBrief | Jul 16, 2008

Bristol-Myers Squibb Co. is expected to pay about $400 million to several states -- including New York, Massachusetts and Missouri -- as part of a settlement announced in September. The drugmaker agreed to pay $515 million to settle claims of Medicaid fraud and unlawful drug-marketing practices and does not face criminal charges. BusinessWeek (07/15)


6. Drug firms eye FDA voucher program for priority review

FDLI SmartBrief | Jul 17, 2008

The FDA's voucher program for priority review begins in September and could change the drug-development landscape for neglected tropical diseases, but many companies are concerned that the vouchers will not ensure a faster time to market and want to see the program in action first. This RPM Report analysis examines the potential value of the program, questions about FDA resources and the drug industry's hesitant interest in the program, and a sidebar examines one company's internal analysis of the program. RPM Report, The (free registration) (07/01)


7. Study: Tea, not coffee, protects brain

FDLI SmartBrief | Jul 18, 2008

Drinking two to three cups of black tea a day can reduce the risk of developing early signs of dementia by almost 50%. The study did not find the same protective results with coffee, meaning it's unlikely that caffeine is the beneficial ingredient. Telegraph (London) (07/17)


8. FDA staffers to be assigned overseas by end of 2009

FDLI SmartBrief | Jul 22, 2008

The FDA is set to station employees in China, India, Europe and Latin America by the end of 2009 to boost the safety of food and drugs imported to the U.S., said Murray Lumpkin, the agency's deputy commissioner of international and special programs. The agency, which also intends to set up offices in the Middle East, awaits final approval from China to permanently assign personnel in the country. Bloomberg (07/21)


9. Merck to finance Vioxx settlement of $4.85B

FDLI SmartBrief | Jul 18, 2008

Merck & Co. announced that it will fund a $4.85 billion settlement of nearly 50,000 lawsuits involving its painkiller Vioxx. The drugmaker made its decision after 97% of eligible claimants enrolled in its settlement program. The first payment of $500 million is scheduled for Aug. 6. Star-Ledger (Newark, N.J.), The (07/17)


10. Lawmakers to examine FDA involvement in Ranbaxy allegations

FDLI SmartBrief | Jul 18, 2008

Democratic Reps. John Dingell and Bart Stupak are set to investigate whether the FDA cleared Ranbaxy Laboratories' products despite prior knowledge of claims that the Indian generic-drug maker falsified data to secure approval. The agency declined to comment on the inquiry, while Ranbaxy denied allegations of fraudulent acts. BusinessWeek (07/17)




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