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A new draft guidance was recently issued by the Food and Drug Administration for how real-world evidence could support regulatory decision making for medical devices. The draft explains how the agency plans to estimate real-world data to determine the sufficiency […]
Dr. BB Chanana at Maharaja Agrasen Hospital, New Delhi said, U.S.Food and Drug Administration (FDA) has accepted the dissolving heart stents in its list of valuable medical devices that can safely be used to save lives from Coronary disease. No […]
A new implant device probuphine, used to treat opioid addiction won approval from the U.S. Food and Drug Administration (FDA). It is the first sub-dermal implant that contains the medication buprenorphine designed to help treat symptoms in people addicted to […]
The Food and Drug Administration (FDA) has approved the use of 3D-only screening mammography using the Siemens Mammomat Inspiration with digital breast tomosynthesis (DBT) system option, said Siemens Healthineers. Previous mammography systems on the market requires a combination of 2D […]
India exports over US $4 billion worth of drugs to the US with Gujarat contributing to about 28% of the drug exports. This is why the US-FDA has an office in India to help regulate the exports and for quality […]
Thai FDA takes tough action against the advertisements on health products which are illegal. The illegal advertisers may have a jail term, fine, website blockade or even cancellation of licenses of broadcasting. “A website falsely advertised that migraine can be […]
During a visit by Indian President to Sweden between 31 May – 2 June 2015, a MoI was signed between India’s Central Drugs Standard Control Organization (CDSCO) and the Swedish Medical Products Agency (MPA). This agreement, complimentary to the ongoing […]
Recently, FDA announced that it would start its Expedited Access Pathway (EAP) program on April 15, a year after it was proposed. EAP Program by the FDA is to: Speed qualifying devices to patients without compromising FDA’s high standards for […]
This article gives a detailed overview on Disinfection and Antiseptic Practices to be included in the Indian Pharmacopoeia to be included in Chapter IP 2026. It will be published officially from July 2024. A comprehensive cleaning and sanitization program is […]