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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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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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ABPI chief exec on the UK industry’s learnings from COVID-19

pharmaphorum

We’ve got so many great life science assets in the UK, but there are still some gaps – manufacturing capacity being one of them.”. “We There have also been many pragmatic collaborations between companies, sites and regulators that have helped keep research and HTA going – such as the more flexible rules introduced by the MHRA.”.

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Pfizer/BioNTech Begin Studies for Third Booster Dose and Development of COVID-19 Vaccine Variants

XTalks

Bourla added that, “At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed.”. The third booster will be given to participants from the Phase I study in the US.

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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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Researchers Discover Genetic Errors and Rogue Antibodies in Cases of Severe COVID-19 Infection

XTalks

The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University. Type I interferons are critical molecular immune regulators that are at the forefront of antiviral responses early in an infection. percent of women and 12.5

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Monkeypox Test Kit in Development by Becton Dickinson in Partnership with CerTest Biotec

XTalks

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.