FDA Finalizes on Controlled Correspondence

FDA Finalizes on Controlled Correspondence

The US Food and Drug Administration (FDA) has finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence process. The guidance incorporates changes that were part of the reauthorization of the...
Supreme Court Settles Fate of DMAA

Supreme Court Settles Fate of DMAA

The U.S. Supreme Court has settled its fate and denied a petition for a writ of certiorari filed by a supplement manufacturer Hi-Tech Pharmaceuticals and its owner, Jared Wheat. The nation’s highest court has rejected a request to review a case involving the legality...
Musclegen Guilty for SARMs Distribution

Musclegen Guilty for SARMs Distribution

The owner of a North Carolina-based sports supplement company Musclegen pleaded guilty to selling unapproved drugs and agreed to forfeit the money earned from the illegal business. Selective androgen receptor modulators (SARMs) are drugs under development for...