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Month: December 2015
FDA approves new orphan drug Uptravi (selexipag) to treat pulmonary arterial hypertension
12/22/2015
On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
December 22, 2015
On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
“Uptravi offers an additional treatment option for patients with pulmonary arterial hypertension,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “The FDA supports continued efforts to provide new treatment options for rare diseases.”
PAH is high blood pressure that occurs in the arteries that connect…
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Identification of Medicinal Products Standards will apply in six Months
The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.
Over the last couple of years the European Health Authorities in conjunction with the International Standards Organization (ISO) have been developing a set of global data standards referred to as Identification of Medicinal Products (IDMP).
The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internally harmonized specifications for medicinal products. The EU is the first to implement these standards, and the other ICH regions will follow. The pharma sector must comply with IDMP standards in the EU region starting July 2016. Following the EU, the other ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries will then begin their own adoption processes to ensure global compliance.
Once the IDMP standards are implemented globally, detailed information about all medicinal products worldwide will, for the first time, be available in a consistent format. This provides regulators with the means of easily comparing product data across regions and with different manufacturers and marketing authorisation holders. This increased transparency will drive numerous patient safety initiatives. It also paves the way for the future roll-out of patient-centric initiatives such as ‘e-prescriptions’.
Adopting the IDMP standard should not only help to achieve regulatory compliance but wants also improve internal business process efficiencies, as well as increase effectiveness between business functions and with external partners, truly enabling a task to value strategy.
For additional information please visit the EMA IDMP Plaza page.
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