In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph…
The FDA issued a Form 483 to Plainville, Connecticut drugmaker AllerQuest for sterility issues and air control deficiencies after an inspection spanning from August to September. Source: Drug Industry Daily
The FDA warned Clover Custom Blending after an investigation of its Tampa, Florida-based manufacturing plant revealed uninvestigated out-of-specification results, missing written procedures and other deficiencies. Source: Drug Industry Daily
Deltona, Florida-based MyNicNaxs entered into a consent decree after admitting to marketing unapproved drugs and misbranding. Source: Drug Industry Daily
Two drug compounders found themselves caught up in FDA’s increased focus on drug compounding when they were slapped with warning letters for the production of adulterated drugs and for sterility…
In a retrial, a jury ordered AbbVie to pay more than $3 million to a plaintiff who blamed his heart attack on misrepresentation of the risks posed by AbbVie’s testosterone…
Senate Health Committee Chairman Lamar Alexander (R-Tenn.) released two draft bills that would provide the FDA with more tools to deal with the opioid crisis. Source: Drug Industry Daily
The Psychopharmacologic Drugs Advisory Committee voted to recommend approval of an NDA for lofexidine hydrochloride for mitigation of opioid withdrawal symptoms. Source: Drug Industry Daily
An FDA inspection of drugmaker Goran Pharma in November netted the company a Form 483 with 17 observations ranging from inadequate employee training to laboratory deficiencies and contamination risks. Source:…
A Delaware federal judge found generic drug developer Alvogen did not infringe on three Invidior patents for the opioid addiction drug Suboxone, specifically relating to the process for drying Suboxone’s…