Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, August 21, 2017
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes a reauthorization of four of the medical product user fee programs, the Prescription Drug User Fee Amendments, Medical Device User Fee Amendments, Generic Drug User Fee Amendments, and Biosimilar User Fee Amendments.
Three of FDA’s medical product center directors discuss importance of the FDA Reauthorization Act of 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
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