Govt brings 8 new medical devices under regulatory regime

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  • July 8, 2021

NEW DELHI: Bringing in more high-end medical equipments such as implants, X-ray machines, MRI and CT scan equipment, and dialysis machines under the purview of drug law, the health ministry on Friday notified eight new devices as ‘drugs’ with effect...

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FDA takes new steps to adopt more modern technologies for improving the security of the drug supply

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  • July 8, 2021

U.S. Food and Drug Administration’s mission is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification...

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Angola FDA team visited Accuprec

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  • July 8, 2021

FDA team from Ministry of Health, Angola visited Accuprec Research Labs Pvt. Ltd. and observed the facilities in the Contract Research Organisation. They received the detail about the Pharma Testing, Formulation & Development, Research,Herbal & Pre-clinical Testing Services provided by...

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Johnson & Johnson to Acquire surgical robotics firm Auris Health, Inc. for US$3.4 billion

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  • July 8, 2021

Focused on creating the next frontier of surgery, Johnson & Johnson has announced that Ethicon, Inc., entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash. Additional contingent payments of up to $2.35 billion,...

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Novartis receives FDA approval for Egaten for the treatment of fascioliasis

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  • July 8, 2021

Novartis has announced that the US Food and Drug Administration (FDA) has approved Egaten® (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease...

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FDA authorizes first interoperable insulin pump for diabetes patients

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  • July 8, 2021

The U.S. Food and Drug Administration today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of...

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Zydus receives final approval from the USFDA for Triamterene and Hydrochlorothiazide Capsules USP

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  • July 8, 2021

Zydus Cadila has received the final approval from the USFDA to market Triamterene and Hydrochlorothiazide Capsules USP (US RLD – DYAZIDE®), 37.5 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The fixed dose...

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e-AUSHADHI portal for Online Licensing System of AYUSH Medicine launched

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  • July 8, 2021

Minister of State (IC) for AYUSH, Shri Shripad Yesso Naik launched the e-AUSHADHI portal, for online licensing of Ayurveda, Siddha, Unani and Homoeopathy drugs and related matters today at New Delhi. Addressing the gathering Shri Naik said that this e-AUSHADHI...

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Doctors must create awareness on the dangers of modern lifestyle: Vice President

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  • July 8, 2021

The Vice President of India, Shri M. Venkaiah Naidu expressed concern over the growing incidence of non-communicable diseases (NCDs) and called upon the medical fraternity to take the lead in promoting healthy lifestyle. Shri Naidu said that also wanted members...

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Guidelines regarding re-use of Medical Devices

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  • July 8, 2021

The Government of India has enacted the Clinical Establishments (Registration and Regulation) Act, 2010 and notified Clinical Establishments (Central Government) Rules, 2012 for registration of Clinical Establishments with a view to prescribing the Minimum Standards of facilities and services provided...

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