Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for three generic drugs.
A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.
FDA grants in part and declines in part a Catalyst Pharmaceuticals petition on using amifampridine to treat congenital myasthenic syndromes.
Novartis asks FDA not to approve ANDAs seeking to produce a generic form of its Entresto under specific conditions.
Federal Register Notice: FDA announces an 11/1 Advisory Committee meeting to discuss ongoing concerns that pulse oximeters may be less accurate in cer...
FDA associate commissioner Mark Abdoo calls for greater collaborative efforts worldwide to combat illicit trade in healthcare products.
FDA says Baxter Healthcares recall of its Clearlink Basic Solution Sets with Duovent is Class 1.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Intra-Cellular Therapies Caplyta.
