The FDA flagged a dozen deficiencies during a September inspection of a Schwabe Mexico facility, including testing and quality problems. Source: Drug Industry Daily

Japanese drugmaker Daito Kasei Kogyo was hit with a warning letter by the FDA for having inadequate testing procedures and falsifying certificates of analysis issued to customers from its facility…

The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections,…

In testimony before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level…

The FDA served Sacutia Healthcare a Form 483 after discovering the company had no quality unit at its St. Helen’s, United Kingdom facility. Source: Drug Industry Daily

Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative announced Monday by two drug industry…

A Chicago jury found AbbVie not liable for an Arizona man’s pulmonary embolism that he blamed on AndroGel, the company’s testosterone replacement drug. Source: Drug Industry Daily

The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. Source: Drug Industry Daily

Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Source: Drug Industry Daily

The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate…