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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'!

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Latest From Ferdous Al-Faruque

Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance

As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers

Distribution Regulation

Bodysphere EUA Blunder Is A Lesson In What Not To Do

Hold back on bragging about your emergency use authorizations until you have them in hand, says one expert after diagnostics company Bodysphere had to backtrack its EUA announcement due to a misunderstanding with the US FDA.

Regulation Commercial

What COVID-19? FDA’s CDRH Sets June In-Person Meeting For Eye Implant Device

The US agency’s Center for Devices and Radiological Health is assembling an in-person advisory committee meeting in early June, the first since the COVID-19 pandemic began. The goal is to discuss the approval of an implant device to treat the natural aging of the eye.

Regulation Commercial

Industry Asks If Small Business Loan Relief Applies To Companies With Equity Investors

A medtech industry group is asking the Trump administration to clarify if small medical device companies that have equity investors qualify for small business loans and forgiveness under the coronavirus relief package.

Policy Commercial

Battelle Decontamination System Gets EUA To Fight Respirator Shortage

The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.

Approvals Companies

Temporary Guidance Relaxes Oversight of Sterilizers, Disinfectant Devices, Air Purifiers

The US FDA published on 29 March an emergency temporary guidance that relaxes oversight of certain sterilizers, disinfectant devices and air purifiers intended to kill the SARS-CoV-2 virus.

Regulation Policy
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