FDA News & Updates
FDA Releases Draft Guidances on Sharing Healthcare Economic Information, Industry Communication Regulations
Two draft guidances released by the FDA in January 2017 explain the regulations in place for pharmaceutical manufacturers and decision-makers within the healthcare field (eg, payers, formulary committees) that share healthcare economic information (HCEI), and how communications should be handled in the industry with regard to drugs and devices that meet FDA labeling requirements, respectively.1,2
FDA Approves First Tissue-Engineered Autologous Cellularized Scaffold Product for the Repair of Cartilage Defects
The FDA has approved Maci, the first tissue-engineered autologous cellularized scaffold product for the repair of symptomatic cartilage in adult patients with knee defects. Maci is composed of cells grown from the patient’s own healthy cartilage tissue, which are then placed onto a bioresorbable collagen membrane and surgically implanted over the area where the damaged tissue was removed.
On April 29, 2016, the FDA approved oxycodone (Xtampza ER) extended-release (ER) capsules, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
The US Food and Drug Administration (FDA) has approved lesinurad (Zurampic; AstraZeneca Pharmaceuticals LP, Wilmington, DE) for use in combination with a xanthine oxidase inhibitor (XOI), which is approved for reducing the production of uric acid in the body, in patients with gout-associated hyperuricemia.
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Results 1 - 10 of 27
Results 1 - 10 of 27