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EUA for Abbott BinaxNOW Covid Antigen Test

[ Price : $8.95]

FDA grants an emergency use authorization for the Abbott BinaxNOW Covid-19 rapid low-cost antigen test.

FDA Approves FoundationOne Liquid Biopsy Test

[ Price : $8.95]

FDA approves Foundation Medicines FoundationOne Liquid CDx biopsy test.

Public Citizen Sues FDA for Seprafilm Petition Answer

[ Price : $8.95]

Public Citizen asks the DC federal court to compel FDA to respond to its 2015 petition asking the agency to ban Baxters Seprafilm....

Mitigate Risk from IoT Vulnerability: Post

[ Price : $8.95]

A Security Intelligence post describes an Internet of Things computer module vulnerability that could adversely affect medical dev...

FDA, LUNGevity Foundation Patient Experience Study

[ Price : $8.95]

The FDA Oncology Center of Excellence and LUNGevity Foundation launch a multi-year study of the real-world experiences of lung can...

Law Professors Voice FDA Concerns

[ Price : $8.95]

Law professors from three universities say FDA commissioner Stephen Hahns misstatement of data supporting the convalescent plasma ...

Recalls Continue Through Pandemic: Report

[ Price : $8.95]

Stericycle says second-quarter medical device and drug recalls remained high despite the economy shut down due to the Covid-19 pan...

Med-El Rondo Hearing Processor OKd

[ Price : $8.95]

FDA approves a Med-EL USA PMA supplement for the slim and lightweight Rondo 3 Audio Processor for use with its Synchrony Cochlear ...

3 DESI Final Determinations Posted

[ Price : $8.95]

FDA posts final determinations for three drugs under the drug efficacy study implementation program.

CNS Cancer Drug Evaluation Guidance

[ Price : $8.95]

FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.