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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'!'}">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'!

Latest From Ferdous Al-Faruque

Interim FDA-Mandated Postmarket Study Finds Essure Has Significantly Higher Rates Of Adverse Events

As expected based on retrospective data, new results from an ongoing postmarket study has found Bayer’s Essure birth control device has significantly higher rates of major adverse events compared to women who undergo tubal ligation.

Regulation Quality Control

Top Democrats: Trump Admin’s COVID-19 Insurance Guidance Poses ‘Serious Threat’

Democratic lawmakers argue the Trump administration’s interpretation of how COVID-19 testing is covered by private insurers runs contrary to the Families First Act and CARES Act. They want the administration to update a FAQ sheet that eliminates certain prerequisites that would qualify patients to be reimbursed for the tests.

Policy Coronavirus COVID-19

BD Gets COVID-19 ‘Game-Changer’ Antigen Test Authorized By FDA

As the US sees another massive spike in COVID-19 cases, public health officials are concerned that not enough testing is available. But the FDA’s EUA for BD’s antigen test could change the game, rapidly testing more of the population for the coronavirus.

Commercial Regulation

Not Renewing COVID-19 Public Health Emergency Could Have Serious Consequences: Lobby Group

Tests may need to be pulled from the shelves if the COVID-19 Public Health Emergency isn’t renewed before it would expire this month, device lobby group AdvaMed claims. But HHS has indicated plans to renew the order.

Regulation Policy

FDA Extends Manufacturers’ UDI Compliance Time Due To COVID-19

Due to the ongoing coronavirus crisis, regulators have put pushed back deadlines for meeting UDI requirements. In some instances, they will no longer require direct-mark UDI information if it can be garnered from other data on the device.

Regulation Coronavirus COVID-19

New Questionnaire Tools Could Help FDA Review Artificial Pancreases

The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.

Regulation Policy
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