US FDA seeks to make permanent its guidance to prevent medical device shortages
Guidance issued by the US Food and Drug Administration (FDA) to prevent supply chain shortages during a public health emergency could be made permanent, the agency has announced.
Under the draft guidance, manufacturers must submit a notification at least six months in advance of a permanent discontinuance that would lead to disruptions to supply in the US. If that is not possible, the FDA should be notified no later than seven days after an interruption occurs, or after the manufacturer decides to permanently discontinue production.
The guidance also recommends that manufacturers and distributors voluntarily provide information to ensure the FDA can help prevent or mitigate shortages in the case of a public health emergency.
Dr. Reddy's partners with academia to build blockchain IoT logistics solution
Dr. Reddy’s Laboratories, one of India’s leading pharmaceutical companies, is developing a new blockchain solution for cold chain logistics in partnership with the University of Hyderabad (UoH).
The goal of the project is to establish a blockchain-integrated Internet of Things (IoT) framework that enables visibility and traceability across the supply chain, to improve vaccine delivery and combat the problem of counterfeit drugs.
Dr Ravi Prakash Mathur, who is co-leading the initiative on behalf of Dr. Reddy’s, commented: “Inventing what the world needs – that is how Edison described the crux of innovation in technology. A good use case for technology is characterized by the problem it is trying to solve and not just the case specifications.
“There are big challenges that technology needs to solve in today's world, especially in the backdrop of the pandemic that we all face. New technologies like blockchain and IoT can offer some of the solutions that we seek.”
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- A.P. Moller-Maersk, the Danish carrier that counts Boehringer Ingelheim and Bayer among its customers, is accelerating its commitment to decarbonizing by moving forward its net zero emission target by 2040 – 10 years ahead of its initial 2050 goal.
- Delta Cargo has approved the Envirotainer Releye to transport pharmaceutical products in secure cold chain environments. Using rechargeable batteries to power its electric heating and compressor cooling system for more than 170 hours on a single charge, Envirotainer says the Releye delivers up to 90 percent less CO2 emissions compared to other available solutions.
- Movilitas, consultants on digital supply chain transformation for the pharmaceutical and medical devices industries, has been acquired by Engineering USA, the North American subsidiary of the Engineering Group. The track and trace experts will be presenting at Pharma IQ’s webinar on the future of regulatory compliance on January 26, find out more here.