Manufacturers of over-the-counter (OTC) drugs: Get ready for change. The Over-the-Counter Drug Safety, Innovation, and Reform Act promises to modify the regulatory system that oversees most OTC medications—and the OTC Monograph system. Anyone who develops and produces an OTC drug for marketing and sale in More..
Thanks to the U.S. Food and Drug Administration’s new FSMA Subpart G rule for human/animal food, the receiver is liable for supplier preventive controls. And there are now 33 sections that outline exactly what receivers must do to comply with these new requirements. The 33 More..
Submitting Abbreviated New Drug Applications (ANDA), especially now, is no straightforward matter. The U.S. Food and Drug Administration (FDA) just released new Generic Drug User Fee Amendments (GDUFA) guidance and yet ANDA submitters are still encountering plenty of ambiguity—even while the FDA is cracking down More..
“Cross recovery” may not be a hot compliance focus area for federal and state auditors at the moment—but stricter scrutiny is on the horizon, says healthcare management consultant Duane C. Abbey. And because the cross recovery issue can rear its ugly head in a number More..
Embezzlement is a depressingly common problem for medical offices, with Healthcare Management Systems reporting that three out of four physicians will suffer a significant loss due to theft in their careers—and, further, that the theft is typically fraud perpetrated by a trusted employee. Medical consultant More..
The medical community has embraced the use of portable devices in health care settings—smartphones, tables, and laptops—both for personal and business uses. This convenience, however, comes with a major caveat—by using portable tech, staff may be violating the Health Insurance Portability and Accountability Act (HIPAA). More..
The opioid epidemic is officially a public health emergency, and more than 100 people are dying in the U.S. each day from opioid-related overdoses. Millions of dollars are being earmarked not only for treatment but also for monitoring requirements under which healthcare organizations are obliged More..
Almost every Food and Drug Administration (FDA) inspection includes a review of standard operating procedures (SOPs), and adverse agency findings often stem from SOP administration issues. Everyone should have good (if not great) SOPs—they are required for all life sciences sector companies. Yet the FDA More..
The Centers for Medicare and Medicaid Services (CMS) recently issued a revision to the Medicare manual that everyone should be familiar with: Teaching physicians can use student documentation for billable services. But the ruling, which was quietly made, comes with plenty of caveats, so if More..
Passage of the Food Safety Modernization Act (FSMA) gave the U.S. Food and Drug Administration (FDA) broader authority to manage product recalls and request records and information from product manufacturers. Additional funding in 2018 is expected to allow for even more sampling and product/facility inspections, More..