Articles By Cyndi Root

91. FDA Pursues Manufacturers And Distributors Of Unapproved Drugs With Codeine 1/22/2014

    The Food and Drug Administration (FDA) announced plans to pursue manufacturers and distributors of unapproved oral and injectable drugs containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrateen. Unapproved drug products escape the FDA's approval process, so there are safety risks to consumers. Some products omit warnings like side effects, dosage instructions, and drug interactions. Additionally, some products misrepresent appropriate ages and children are at risk of using adult products and doses.

92. The FDA Charters A Vaccines And Related Biological Products Advisory Committee 1/21/2014

    The Food and Drug Administration (FDA) updated the Vaccines and Related Biological Products Advisory Committee page on its website on January 9, 2014. The information presented helps interested parties learn about the committee’s charter, its authority, and the scope of its activities. The purpose of the committee is to “ensure safe and effective drugs for human use.”

93. The FDA Gives Merck's Vorapaxar A Positive Review 1/21/2014

    The Cardiovascular and Renal Drugs Advisory Committee, a Food and Drug Administration (FDA) committee, voted to approve Vorapaxar in a 10 to 1 vote. The drug, sponsored by Merck Sharp & Dohme Corp., Inc., is for patients with Myocardial Infarction (MI). The FDA can reject or accept the committee’s recommendation, but the agency takes the committee’s advice seriously, and in most cases issues final approval. If the new drug is approved, Merck plans to market it as Zontivity.

94. First Gel For Cataract Surgery Approved By The FDA 1/16/2014

    Physicians in the U.S. have a new method to seal incisions after cataract surgery. The Food and Drug Administration (FDA) has approved ReSure Sealant, a synthetic gel to protect corneal incisions after intraocular lens placement. Ocular Therapeutix, a privately held company in Bedford, Mass., manufactures the gel.

95. The FDA Takes Control Of E-Cigarettes 1/10/2014

    The Food and Drug Administration (FDA) is expected to issue rules on electronic cigarettes, also called e-cigarettes or e-cigs. “The FDA intends to propose a regulation,” said Jenny Haliski, press officer for the FDA, “that would extend the agency’s ‘tobacco-product’ authorities.” Currently, the FDA controls tobacco but not tobacco products like e-cigarettes.