Worldwide Clinical Trials

JULY 8, 2024

Individuals with familial cancer syndrome may have inherited mutations that predispose them to cancer development, affecting genes involved in DNA repair and cell cycle regulation. Similar to the FDA, the EMA evaluates radiopharmaceuticals for safety, efficacy, quality, and GMP regulation compliance before granting marketing authorization.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

pharmaphorum

SEPTEMBER 22, 2021

The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. Software that can help pathologists detect prostate cancer from slides of biopsies more effectively has been approved by the FDA.

In-Vitro 106

In-Vitro Radiology Regulation Trials 106

pharmaphorum

JUNE 3, 2021

Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence. .

Doctor 112

Doctor Doctors Radiology Development 112

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. Criteria for regulation.

Development 105

Development Regulation Cosmetics Life Science 105

FDA Law Blog

MAY 22, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. By Jeffrey N.

Radiology 59

Radiology Regulation Marketing 59

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). Javitt & Allyson B.

Regulation 59

Regulation Radiology Cosmetics In-Vitro 59

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.

Radiology 52

Radiology Scientist FDA Approval Regulation 52

FDA Law Blog

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That Rule requires data companies to notify consumers and regulators of unauthorized disclosures of consumers’ personal health information.

Radiology 105

Radiology Regulation Compliance Marketing 105

FDA Law Blog

APRIL 20, 2021

To date, FDA had not updated its classification regulations, the FDA regulations defining categories of devices and outlining the applicable regulatory controls, to carve out the categories of software devices excluded from the device definition by the Cures Act. Certain types of clinical decision-support software. 21 C.F.R.).

Regulation 40

Regulation Radiology 40

pharmaphorum

FEBRUARY 3, 2021

The information comes from preoperative radiological imaging data and aims to guide the surgeon during operations, increasing precision. The company aggregates imaging and clinical data in compliance with ethics and regulations, and provides hospitals with clinical data warehouses.

Radiology 63

Radiology Compliance Doctor Doctors 63

XTalks

MAY 21, 2024

Collaborative efforts with the International Council for Harmonisation (ICH) and the International Medical Device Regulators Forum are pivotal in this regard. Device and Radiological Health Innovations In October 2023, the FDA’s Center for Devices and Radiological Health has celebrated a decade of the Early Feasibility Studies (EFS) Program.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Clinical Research 64

XTalks

SEPTEMBER 9, 2022

George, MD, distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina, in Magnus Medical’s press release.

Radiology 98

Radiology Life Science Licensing Licensing 98

FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

Regulation 69

Regulation Production Radiology Development 69

FDA Law Blog

NOVEMBER 21, 2022

One cause of death in this “valley” is related to the need to understand and meet regulator expectations. Devices regulated by the Center for Biologics Evaluation and Research (CBER) and combination products are outside the scope of the TAP Pilot. By Adrienne R. Food & Drug Admin., 11, 2022) [hereinafter “ Announcement ”].

Regulation 59

Regulation Production Radiology Development 59

FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. 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.

In-Vitro 69

In-Vitro Radiology Cosmetics Medicine 69

XTalks

OCTOBER 26, 2022

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has moved forward with a plan to minimize the risks of breakthrough medical devices by introducing its voluntary Total Product Life Cycle Advisory Program (TAP) Pilot.

Production 98

Production Radiology Marketing Development 98

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

pharmaphorum

SEPTEMBER 8, 2022

The open-access resources were developed over a period of 9 months, based on a mixed-methods study and comprehensive literature review, a series of workshops and focus groups with payers, as well as meeting with regulators.

Dermatology 52

Dermatology Production Radiology Development 52

XTalks

APRIL 6, 2021

Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators. The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

XTalks

DECEMBER 14, 2023

We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA’s news release. “We

In-Vitro 52

In-Vitro Regulation Manufacturing Radiology 52

Cloudbyz

JULY 31, 2024

Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.

Compliance 52

Compliance Trials Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 15, 2022

director of the FDA’s Center for Devices and Radiological Health. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. for the next public health emergency.”. Source link: [link].

Radiology 52

Radiology Cosmetics Production Licensing 52

pharmaphorum

DECEMBER 11, 2022

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. When you get to a regulated intervention, evidence generation, validation of claims all the way to pricing and reimbursement – then, we’re talking about digital therapeutics.”.

Life Science 137

Life Science Clinical Research Development Research 137

FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

In-Vitro 69

In-Vitro Regulation Production Development 69

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

Radiology 40

Radiology Production Regulation Manufacturing 40

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

Regulation 52

Regulation Medicine Radiology Cosmetics 52

FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Containment 52

Containment Radiology Cosmetics Manufacturing 52

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 20, 2022

director of the FDA’s Center for Devices and Radiological Health. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Source link: [link].

Genetics 52

Genetics Cosmetics Radiology Production 52

FDA Law Blog

OCTOBER 10, 2022

The final CDS Guidance represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be Non-Device CDS or low-risk Device CDS under enforcement discretion.

Regulation 52

Regulation In-Vitro Development Radiology 52

The Pharma Data

NOVEMBER 12, 2021

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].

Cosmetics 40

Cosmetics Compliance Production Manufacturing 40

The Pharma Data

NOVEMBER 17, 2020

director of FDA’s Center for Devices and Radiological Health. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. . .

Radiology 40

Radiology Cosmetics Production Doctor 40

Advarra

APRIL 30, 2024

For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. In some countries, local regulations may indicate the sub-investigators need to sign as well. Remember, some staff may not need protocol-specific training.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

Delveinsight

SEPTEMBER 2, 2021

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.

Marketing 72

Marketing Radiology Drugs Drug Delivery 72

The Pharma Data

NOVEMBER 6, 2020

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.

Marketing 40

Marketing Production Radiology Regulation 40

XTalks

NOVEMBER 7, 2022

Prospective clinical trials are needed to explore whether changing therapy based on ctDNA dynamics prior to radiologic or clinical progression will improve outcomes compared to our current standard,” added Dr. Bahassi. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

AUGUST 30, 2022

A consideration is that for early-stage studies, the regulators usually are happier with a staged unilateral followed by a bilateral procedure to evaluate risks first,” explains Dr. Rodrigues. The Neurology and Radiology departments are vital for consultation and imaging, which is needed to establish baselines for a study.

Trials 83

Trials Drug Delivery Drugs Gene 83