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FDA seeks public comment on questions related to drug and biological product shortages

USA - February 13 2013 Pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, the Food and Drug Administration…

Shahnam Sharareh, PharmD, RAC.

Will the threat of personal liability stifle corporate activity?

USA - April 2 2012 Both the federal Food and Drug Administration (FDA) and Office of the Inspector General (OIG) have authority to seek personal consequences against corporate officers deemed responsible for federal health care violations.

HHS/OCR audits are almost here - OCR issues "sample" audit letter

USA - December 1 2011 Last month a posting was made on this blog series regarding action being taken by the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) relating to the fact that government audits for HIPAA compliance with privacy and security standards are finally beginning.

USEPA increases focus on stormwater management

USA - January 25 2011 Stormwater permits are designed to control run-off of deleterious materials and improve the environment.

Government suggests drug coupons do not violate the anti-kickback law

USA - October 2 2012 Today, I was intrigued by a Washington Post article about branded drug companies offering discount coupons to stave off competition from generic drug manufacturers.