Which Regulatory Path Should I Choose for FDA Combination Products?

With FDA Combination Products on the Rise, a Common Question is, “Which regulatory path should I choose?”

What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. To be considered a combination product by FDA, there must be two or…

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Taking a drug holiday

Drug Holidays – Temporary Suspension of Therapy; Drug Labeling Consultant’s Perspective

Drug holidays are not often described in the U.S. professional labeling of prescription drug products. However, they are routinely employed across various classes of drugs as well as a variety of patient populations. As the name implies, a drug holiday is the temporary suspension of active therapy[1], and is usually enacted to avoid adverse events…

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FDA Issues Final Hatch-Waxman Rule Implementing Certain Provisions of the 2003 Medicare Modernization Act

Following is an excerpt from the Executive Summary (Click here for the Final Rule; 81 FR 69580) “Title XI of the MMA addressed two key concerns identified in a Federal Trade Commission (FTC) report on anticompetitive strategies that may delay access to generic drugs by: (1) Limiting the availability of 30-month stays of approval on…

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FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances

“To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.” On…

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FDA Issues New Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Deadline for Submission of Comments November 21, 2016

FDA has released a new draft guidance “intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time. The draft guidance is intended to address concerns that new FDA-approved…

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2016 Nobel Prizes in Physics, Chemistry & Physiology Announced

October 3-5, 2016: Nobel Prizes in Physics, Chemistry and Physiology Announced • Physics 2016: David J. Thouless, F. Duncan M. Haldane and J. Michael Kosterlitz for “theoretical discoveries of topological phase transitions and topological phases of matter” • Chemistry: Jean-Pierre Sauvage, Sir J. Fraser Stoddart and Bernard L. Feringa “for the design and synthesis of…

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QMS Risk Management

Do I Need a Medical Device Consultant to Review My Quality Management System (QMS) and/or Help with My 510(k) Submission?

What is a Quality Management System (QMS)? As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It doesn’t take more than one FDA inspection to figure this one out. If you are involved in, or considering entry into the medical…

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Multiple Antiseptic Wash Ingredients May No Longer Be Marketed-FDA Issues Final Rule

FDA has “issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than…

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