Monday, August 21, 2017

The Center for Veterinary Medicine (CVM) is pleased to announce a CVM-only version of FDA’s eSubmitter tool. This new software package is independent from the FDA eSubmitter program. The new CVM eSubmitter tool is available for download as of August 21, 2017.
CVM eSubmitter is an electronic, question-based submission tool for creating information to be transmitted electronically to FDA through its secure Electronic Submission Gateway (ESG). eSubmitter uses data-capturing templates to allow users to assemble a complete and appropriately structured submission to CVM. The templates, available for all submission types varying from simple to complex, were developed by CVM subject-matter experts.

Sunday, August 20, 2017

20-plus health care stats that will blow you away

USA TODAY-Aug 18, 2017
$3.2 trillion: The United States spends a whopping sum on health care. The total U.S. healthcare expenditure in 2015 was $3.2 trillion, per the Centers for

FDA mulls change to drug ad rules

The Pharma Letter (registration)-Aug 18, 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing statements about drug safety in ...

FDA to Cut Back Hiring of Non-US Citizens

The Scientist-Aug 14, 2017
FDA building with sign FDAHiring managers at the US Food and Drug Administration (FDA) will soon be unable to extend offers to non-citizens who have lived ..

Congress Weighs Expanding FDA Power to Regulate Beauty Products

Congress Weighs Expanding FDA Power to Regulate Beauty Products

Wall Street Journal (subscription)-Aug 18, 2017
Yet six years after a consumer-safety group petitioned the agency to ban the products, the FDA has taken little action and said recently it is still studying the issue ...