Advancements in the dynamic field of biotechnology are bringing about the development of innovative, new food products. At the U.S. Food and Drug Administration, we’re committed to helping food developers bring biotechnology innovations to market while at the same time providing consumers with confidence that foods available for purchase in the U.S. – whether developed using traditional breeding techniques or biotechnology – meet the FDA’s high safety standards.
A new study finds vitamin D may be protective among asthmatic obese children living in urban environments with high indoor air pollution. The study out of John Hopkins University School of Medicine, funded by the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, was published in The Journal of Allergy and Clinical Immunology: In Practice.
U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples common devices used in many surgeries and to provide updated recommendations to help reduce risks associated with their use.
Since the biosimilar pathway was established in 2010, there’s been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance. Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition.
Eighty-six percent of individuals who entered HIV care soon after diagnosis maintained viral suppression after 48 weeks during a clinical trial conducted at four National Institutes of Health-funded Centers for AIDS Research (CFARs) across the United States. Participants in the clinical trial, called iENGAGE, achieved viral suppression in an average of just 63 days. The findings were presented in a poster at the Conference on Retroviruses and Opportunistic Infections(link is external) (CROI 2019) in Seattle.
Among people with HIV in Latin America, those diagnosed with tuberculosis (TB) at an initial clinic visit were about twice as likely to die within 10 years as people not initially diagnosed with TB, according to findings from a large observational study.
New HIV infections declined by 30 percent in southern African communities where health workers conducted house-to-house voluntary HIV testing, referred people who tested positive to begin HIV treatment according to local guidelines, and offered other proven HIV prevention measures to those who tested negative. Local guidelines evolved during the study from offering HIV treatment based on immune health to offering immediate treatment for all.
New findings from a large, randomized clinical trial that compared two infection control techniques are already being incorporated into practice within the network of U.S. community hospitals where the trial took place.
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus.
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisationin the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.