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FDA Slows Down

Pharmalot's Ed Silverman says the Food and Drug Administration's new, slower pace for drug approvals is probably the "new normal" for the regulatory body. A new study from Parexel Consulting in Boston shows that the rate of first-cycle drug approvals FDA makes is slowing, and that there's a "significant and ongoing decline" in priority-designation rates, Silverman says. Parexel Consulting found a 25 percent decline in first-cycle approvals for new drugs and a 17 percent decline in priority designations for NDAs between 2008 and 2009, which the firm attributes to FDA's Safety First Initiative and new risk management strategies, among other things. Overall, Silverman says, the agency's actions on diabetes drug Avandia are indicative of its "new normal."

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.