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Ferdous Al-Faruque

Senior Reporter

Washington, DC
Ferdous Al-Faruque, known as Danny, specializes in reporting on new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security. He is also our resident podcast expert, and has brought listeners the voices of top FDA officials as well as industry leaders. Danny is a big sci-fi fan, especially Battlestar Galactica and Star Trek. Qapla'!
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Latest From Ferdous Al-Faruque

Device Week, 10 January 2020 – A Look At US Legislation That Could Touch Medtech In 2020

On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector.

Device Week United States

How A Pro-Software Patent Bill Could Affect The Medtech Industry

Though it didn’t even get to committee, a bill to make it easier for tech companies to patent software – including medical software – has a good chance of getting passed in Congress this year, bill proponents and legal experts say.

Policy Commercial

FDA Will Keep Listening To Patient-Engagement Experts

The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.

Regulation Advisory Committees

Partnerships Are Key To Foundation Medicine's Success

Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.

Commercial Approvals

More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions

New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.

Regulation FDA

More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions

A new FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.

Regulation FDA
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