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Arnall Golden Gregory LLP

Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning Letter to a Medical Device...

Arnall Golden Gregory LLP on

One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Stinson LLP

FDA Draft Guidance and Pilot Program Seek to Expand Device Modifications Appropriate for the Special 510(k) Program

Stinson LLP on

In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand...more

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