The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.
The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.
The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.
A bipartisan bill that calls for a collaborative, coordinated approach to curbing prescription drug abuse and safeguarding patients is headed to the U.S. House for a vote.
Legislation that would speed up and streamline the Food and Drug Administration’s approval process for new sunscreen ingredients passed the House on Monday, according to published reports.
The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17.
The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.
The National Association of Specialty Pharmacy and the Specialty Pharmacy Association of America announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy.
The Consumer Healthcare Products Association celebrated the first International Self-Care Day event in the United States.
The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), a long-acting opioid analgesic.