While flavor declarations are a cinch, the FDA labeling requirements for the flavor designation on the principal panel display are complex and confusing. Even conventional foods and dietary supplements can be difficult to label when it comes to the FDA’s required Statement of Identity—get things More..
The American dietary supplements market remains strong, but due to U.S. Food and Drug Administration rules for dietary supplement labeling, moving products to market and placing them on store shelves is a cumbersome process. Even a slight slip up can lead to warning letters, fines, More..
With new products in the pipeline, new technologies on the horizon, and the hint of coming regulatory shakeups, 2019 promises to be an interesting year for the medical devices industry. And, while the year holds plenty of promise for those who are well-positioned to capitalize More..
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..