Deltex Injunction Demonstrates Need For Fast Response To FDA Inspections
This article was originally published in The Tan Sheet
An injunction prohibiting Deltex Pharmaceuticals from making drugs until it complies with good manufacturing practices and other regulations reminds firms that "the leash may not be as long" under the current FDA as in the past, a health care attorney says.
You may also be interested in...
FDA will warn firms only once - if at all - before taking stronger enforcement actions to stop systematic quality and safety problems, said Howard Sklamberg, director of the Office of Enforcement at the Office of Regulatory Affairs
About one-third of the 90 dietary supplement good manufacturing practices inspections FDA completed in fiscal 2010 by the start of September revealed serious compliance problems, according to Principal Deputy Commissioner Josh Sharfstein
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.