Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.
Legislation recently introduced by U.S. Rep. Tom Marino, R-Pa., which is intended to reduce the abuse of prescription drugs by fostering greater collaboration among stakeholders and implementing new safeguards, has received the endorsement of the National Community Pharmacists Association.
The West Virginia Senate on Tuesday voted 25-to-9 to make pseudoephedrine a Schedule IV prescription drug and exempt medicines that can’t easily be diverted to methamphetamine, according to published reports.
The Electronic Retailing Self-Regulation Program recommended that truDERMA discontinue certain claims for the company’s Troxyphen dietary supplement, including claims that the product is “safe and clinically researched.”
From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.
In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.
The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).