FDA Law Blog

NOVEMBER 5, 2023

Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. The comprehensive agenda for the symposium can be accessed in its entirety here.

Radiology 52

Radiology FDA Approval Regulation Scientist 52

The Pharma Data

NOVEMBER 18, 2020

. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

FDA Approval 52

FDA Approval Vaccination Vaccine Genetics 52

Drug Discovery World

NOVEMBER 29, 2023

The most important benefit is that we now have an accurate model that we can use to perform virtual experiments with different types of interventions, quickly and digitally.”

Development 52

Development Drugs Radiology Drug Trials 52

pharmaphorum

NOVEMBER 16, 2021

Now, FDA approval means that it can continue to be sold outside of the public health emergency. Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been place correctly.

FDA Approval 145

FDA Approval Radiology Development 145

XTalks

JANUARY 26, 2024

As of October 19, 2023, there were 692 FDA-approved devices linked to AI/ML , underscoring the expanding role of these technologies in healthcare. It promotes unique insights and improvements in tumor biology understanding through the collaboration of biological and computer scientists.

Research 118

Research Gene Editing Gene Genetics 118

The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

FDA Approval 52

FDA Approval Radiology Doctors Doctor 52

XTalks

MARCH 27, 2023

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

XTalks

APRIL 27, 2021

With the authorization, the IpsiHand System becomes the first non-invasive neurological rehabilitation device to receive FDA approval in the rapidly growing brain-computer interface space.

Radiology 105

Radiology Development FDA Approval Containment 105

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

OCTOBER 6, 2021

CT imaging is a key non-invasive medical tool used in the diagnosis and monitoring of disease and injury. With no major innovations in the field for nearly a decade, the new photon-scanning technology may transform CT imaging by making it more detailed and efficient by drastically improving image quality.

FDA Approval 98

FDA Approval Radiology Research Development 98

Intouch Solutions

JUNE 30, 2022

The Roblox pseudo-metaverse now includes a partnership with ADHD therapy (gizmodo.com) – Roblox is partnering with Akili Interactive, creators of EndeavorRx (a game that is an FDA-approved ADHD treatment for children 8-12), to “create new ways for patients to engage in health through the Roblox platform.”

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. It is characterized by progressive fibrosis, lung scarring, and a radiological pattern known as usual interstitial pneumonia, or UIP.

Drugs 40

Drugs FDA Approval Marketing Containment 40

Drug Discovery World

APRIL 14, 2023

Carolyn R Bertozzi, PhD – Outstanding Achievement in Chemistry in Cancer Research Bertozzi is the Baker Family Director of Sarafan ChEM-H, the Anne T and Robert M Bass Professor in the School of Humanities and Sciences, Professor of Chemistry and, by courtesy, of Chemical and Systems Biology and of Radiology at Stanford University.

Genetics 52

Genetics Research Medicine Clinical Research 52

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

FDA Approval 40

FDA Approval Drugs Medicine Genetics 40

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

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Trials Drug Delivery Drugs Gene 83