FDA Regulations Archives - Q1 Productions

FDA Regulatory Issues and Solutions

Jeff Gibbs from Hyman, Phelps & McNamara will be participating in the panel “Optimizing Primary Mode of Action Determination & Process to Appeal FDA Decisions” at Q1’s Combination Product Regulation Conference. See what he has to say on FDA regulatory issues...

FDA Finalizes New Nutrition Facts Label

Last week, the FDA announced that “[The FDA] finalized the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The new label will make it...

BREAKING: FDA Would Allow Biosimilar Labels to Rely on Reference Drug Data

In a new article via Modern Healthcare, “Biologic manufacturers may not be pleased with the long-awaited biosimilar labeling guidelines released by the Food and Drug Administration on Thursday.” For more information, please visit:...

FDA Grants Premarket Approval for New Heart Pump

The FDA has approved the first hemodynamic support device from AbioMed. The Impella 2.5 System has gained “premarket approval for use during high risk PCI procedures” according to an article via Forbes.com. The blood pump will be a temporary device for...

How to Win with the FDA

Getting regulatory approval from the FDA can prove to be a lengthy and frustrating process, with many procedures and processes that must be followed. Take a look at this article about “a heated public debate that took place during a recent FDA advisory...

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