FDA Regulations

Full text of all of the FDA regulatory requirements for food, drugs, cosmetics, and medical devices (including tentative final monographs for OTC drugs), DEA requirements for controlled substances, Consumer Product Safety Commission requirements regarding poison prevention, and U.S. Custom Service requirements for importation and export. Select from the list of FDA Regulations products below:

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Topic Spotlight

Cardiovascular risk in antidiabetic therapies; guidance

The FDA released a guidance making recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.

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Topic Spotlight

Orphan product development grants available

The FDA's Office of Orphan Product Development (OPD) will give grants totaling over $14 million in fiscal year (FY) 2010 for orphan product studies. The office anticipates similar funding for FY 2011.

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