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Patients unable to establish general causation between IUD and intracranial condition
General causation was threshold issue in the medical device litigation, and the knowledge of lay jurors is not sufficient to decide issue of complex science.
New e-cigarette products subject to premarket tobacco product application requirements
A new guidance clarifies when premarket approval is required for a new electronic nicotine delivery system and what specific considerations applicants should take in to account in preparing their...
Co-owner and manager of medical compounding facility involved in 2012 meningitis outbreak acquitted on fraud charges
Federal judge finds the owner and manager of a drug compounding facility not guilty of conspiring to defraud the FDA because the FDA did not have regulatory oversight over compounding facilities.
Personal care home license not fundamental property interest
The Pennsylvania Department of Human Services was not required to convene a pre-deprivation hearing prior to revoking a "regular" personal care home license and issuing a "provisional...
CMS wants public input on how to cut red tape in the health care system
CMS’s Patients over Paperwork initiative has made great progress in eliminating needlessly complex, outdated, or duplicative requirements that take clinicians’ focus away from patient...