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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Fantastic News – EU initiative: Extension of the transition period for medical devices

Pharma Business Blog

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. Sandra Ragaz, Partner, Leader Pharma & Life Science – International Indirect Tax & Regulatory Sandra.ragaz@pwc.ch

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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

This results in anemia, characterized by a decreased number of RBCs, and jaundice, indicated by high bilirubin levels, typically appearing within the first days or weeks of life. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

Trials 78
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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

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Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

The Pharma Data

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

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The Challenges and Promise of CAR T-Cell Therapy in Oncology

XTalks

With a PhD in immunology and a career rooted in Philadelphia, Nick’s path was inspired by his interactions with prolific life science executives and witnessing groundbreaking innovations from institutions like Penn and the Children’s Hospital of Philadelphia (CHOP).