Drugs In-Vitro Radiology 
FDA Law Blog
AUGUST 18, 2024
Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.
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XTalks
JULY 13, 2022
The Minuteful Kidney test is Healthy.io’s most recent innovation that has acquired 510(k) clearance from the US Food and Drug Administration (FDA). It has become the first-ever digital home kidney test to enable early warning of kidney disease. Around one in three adults in the US (or about 80 million Americans) are at risk of developing CKD.
FDA Law Blog
DECEMBER 11, 2023
Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It
XTalks
DECEMBER 14, 2023
The US Food and Drug Administration (FDA) is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 CPAP machines used to treat or manage obstructive sleep apnea. It is used at home and in clinical settings.
FDA Law Blog
FEBRUARY 4, 2024
Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.
The Pharma Data
OCTOBER 22, 2020
Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. .–(BUSINESS WIRE)–Oct.
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