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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. for the next public health emergency.”.

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FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Source link: [link].

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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].

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FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

The Pharma Data

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. The FDA granted the marketing authorization to Nightware, Inc.

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Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy

Delveinsight

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

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Sunday 16 April at AACR Annual Meeting 2023

Drug Discovery World

DDW’s Megan Thomas rounds up highlights from Sunday 16 April at AACR 2023, from promising trial results for a personalised mRNA-based cancer vaccine to winners of lifetime achievement awards. She is also an investigator with the Howard Hughes Medical Institute.

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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

The Pharma Data

director of FDA’s Center for Devices and Radiological Health. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. . .