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FDA Cracks Open Door For More Manufacturer Communications

 
• By Elizabeth Orr

Two draft guidance documents would allow a broader range of communications with payers and others about information not included on device labeling, or concerning products without FDA approval.

US FDA issued two question-and-answer format draft guidance documents, on Jan. 18 that attempt to clarify the agency’s stance on manufacturer communications in a range of circumstances. a

The first draft guidance explains how FDA expects manufacturers to discuss investigational products with insurance companies and other payers. The second reviews the agency’s thinking on...

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More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.