OTC Drug

OTC Drug Compliance Reform Act Will Impact Your Current & Future Offerings

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 the U.S. needs to understand the changes the OTC...

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Heed New ANDA Requirements—Or Risk a Swift FDA Rejection

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 on unsatisfactory ANDA submissions. The key to applicants’ success...

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Medical Office Embezzlement

Root Out Medical Office Fraud: Limit Cash Access & Look for ‘Fraud Triangle’

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 Jill Young maintains that focus on fraud prevention and...

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mobile devices

Mobile Tech Can Transform Healthcare—and Expose Patient Records

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). Healthcare compliance pro Jim Sheldon-Dean explores the use of...

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