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
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more
Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more