Mark Kramer answers 5 questions on comination products and the regulatory hurdles manufacturers can face.

1. What is a combination product?

A combination product is a combination of different types of regulated products, i.e., a drug and a device, a drug and a biologic, a device and a biologic, or a combination of a drug, device and biologic. FDA recognizes 3 types of combination products, where the components are (1) physically/chemically combined into a single entity (like a drug-coated catheter), (2) packaged together, or (3) separate products brought together through their labeling (“cross labeling”). The US is unique in recognizing cross labeled components as combination products, and these sometimes raise challenging regulatory issues.

2. How does FDA...

A letter to to the New York Times was published yesterday, from AdvaMed Spokesperson, Christopher L. White. In it, White establishes support for the Physician Payment Sunshine Act, saying it "complements our code of ethics."

The editorial comes in response to several opinion pieces published over the last few weeks, since CMS issued its draft guidance: 

• One was from Thomas P. Stossel in the Wall Street Journal, in which Stossel concludes that patients, physicians, and manufacturers lose ground, while "accountants, compliance bureaucrats, and the legions of lawyers" rake in profits and troll the "Sunshine" database to further find evidence of wrongdoing. He also says that critics of such payments have failed to find evidence that...

Further Reading:

Who Paid for Your Doctor's Bagel?

Impending new medical device regulations in Russia are expected to make the regulatory system more streamlined. The regulations are expected to be released in the next few weeks. A blog post on medtechinsider details the expected changes in more detail.

One of the reasons Russia is changing its regulatory system is to make it easier for medtech manufacturers to export their products, said Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, in an interview with EMDT Editor in Chief Norbert Sparrow last November. Medical device registration in Russia is challenging, especially for foreign companies, and you can't easily get answers by picking up the phone. According to the...