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The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
The U.S. Food and Drug Administration approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.
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The government is encouraging enrichment of food items with micronutrients to remove dietary deficiencies among its citizens, Minister of State for Health and Family Welfare Ashwini Kumar Choubey said.
In order to promote fortification as a means to address micro nutrient deficiencies, the Food Safety and Standards Authority of India (FSSAI) has operationalised the draft Food Safety and Standards (Fortification of Foods) Regulations, 2016 in October 2016, he said in a written reply to the Rajya Sabha.
Choubey said FSSAI has established Food Fortification Resource Centre in collaboration with Tata Trusts and various international NGOs working in the field of nutrition as a resource centre to promote large-scale fortification of food and to nudge and facilitate food businesses to adopt fortification as a norm.
At present, all the major oil producers in the country are voluntarily fortifying at least one brand in their product portfolios, he said.
The regulations include provisions regarding standards for fortification of food articles namely wheat flour, rice, milk, edible oil and salt with vitamins and minerals, said the minister to a query on the laws for food fortification in the country.
The FSSAI may from time to time mandate fortification of any food article under the regulations on the directions of the Central or the state governments in consultation with stakeholders, he added.
The Women and Child Development Ministry and the Human Resource Development Ministry have advised the use of double fortified salt with iron and iodine, wheat flour with iron, folic acid and vitamin B-12, and edible oil with vitamin A and D under their Integrated Child Development Scheme and Mid-day Meal Scheme.
Under Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011, sale of only iodized salt is permitted for direct human consumption.
Further, Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 provide that vanaspati should contain synthetic Vitamin A.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation.
Foods for special medical purpose (FSMPs) is a category of foods that has been harmonised with the IMS Act to save the lives of babies suffering from inborn errors of metabolism (IEM), a life-threatening medical condition affecting thousands of infants in the country.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a revised guideline on clinical studies for medicines that target Alzheimer’s disease. This document aims to provide guidance for the development of medicines across all stages of Alzheimer's disease.
The European Medicines Agency (EMA) has started an urgent review of the multiple sclerosis medicine Zinbryta (daclizumab) following 7 cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.
The National Pharmaceutical Pricing Authority fixes/revises the price of the Scheduled formulation.
The scheduled formulations are: Atorvastatin + Aspirin Capsule (Atchol-ASP 150), Nifedipine + Lidocaine Cream (LOXHEAL), Pioglitazone + Gliclazide + Metformin Tablet (GLZ Total), Ibuprofen + Paracetamol Tablet (Brufen Plus), Misoprostol Tablet, Glimepiride + Metformin Tablet, Melphalan + Povidone Injection (Melphalan Injection IP 50mg), Trastuzumab Injection, Vitamin D3
(Cholecalciferol) (DRISE SURE), Furosemide Injection, Snake Venom Antiserum-Soluble/ Liquid Polyvalent Injection, and Phenobarbitone oral liquid.
The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide.
U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. The agency protecting consumers of unapproved products claiming to prevent, treat or cure influenza, or flu.
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