Cloudbyz

JULY 31, 2024

The Principal Investigator (PI) of any study, be it drug or device, has many responsibilities, including ensuring regulatory compliance, overseeing the conduct of the study, and safeguarding the well-being of study participants.

Compliance 52

Compliance Trials Clinical Trials Clinical Trials 52

FDA Law Blog

FEBRUARY 20, 2023

GoodRx is alleged to have shared ostensibly protected personal health information with other tech companies, used the data for ad targeting, allowed third-party use of the data, used a HIPAA seal on its site that misrepresented its compliance status, and failed to put other policies in place to protect the data.

Radiology 105

Radiology Regulation Compliance Marketing 105

Worldwide Clinical Trials

JULY 8, 2024

Similar to the FDA, the EMA evaluates radiopharmaceuticals for safety, efficacy, quality, and GMP regulation compliance before granting marketing authorization. International Commission on Radiological Protection (ICRP) The ICRP provides recommendations and guidance on radiation protection standards for occupational and public exposure.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

XTalks

SEPTEMBER 5, 2024

The trials, published in Radiology , involved 44 patients and 49 tumors — ranging from primary liver cancers to metastatic tumors. HistoSonics announced the results of its pivotal #HOPE4LIVER trials, showcasing the Edison Histotripsy System’s effectiveness in non-invasively destroying liver tumors.

Trials 52

Trials Radiology Compliance Production 52

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.

Development 105

Development Regulation Cosmetics Life Science 105

WCG Clinical

MARCH 17, 2023

Understand the Value of Coverage Analysis Coverage analysis forms a valuable basis for billing compliance, as it helps prevent double billing. Sites performing device studies should be aware of Medicare Benefit Policy Manual Chapter 14, which includes billing compliance rules for investigational device exemption (IDE) studies.

Compliance 52

Compliance Clinical Trials Clinical Trials Trials 52

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.

Regulation 59

Regulation Radiology Cosmetics In-Vitro 59

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We During the examination, the FDA investigator made several compliances that are outlined in an examination bonus report, also known as an “ FDA Form 483.” The FDA investigator handed a list of their compliances to the company.

Cosmetics 40

Cosmetics Compliance Production Manufacturing 40

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. Prefilled syringes are syringes that come pre-filled with a specific dose of medication.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance lists four general types of medical information that would meet the definition of “medical information about a patient”—a radiology study report, an ECG report, a blood pressure result, and a lab test result—but these examples shed little insight on how to apply the interpretation in practice.

Regulation 52

Regulation In-Vitro Development Radiology 52

FDA Law Blog

DECEMBER 11, 2023

Meanwhile, given the compressed enforcement discretion phaseout timeline proposed by FDA, upon issuance of a final rule (which could occur while MDUFA V is still in place) laboratories would need to immediately begin compliance efforts, including by filing pre-submissions. 360(m)(a)(3). [16] 31, 2023), [link]. [17] 15, 2017), [link]. [18]

In-Vitro 69

In-Vitro Regulation Production Development 69

XTalks

JUNE 12, 2023

Siemens Healthineers further demonstrated its commitment to innovation at the European Congress of Radiology in Vienna, showcasing its revamped Acuson ultrasound portfolio. Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

MAY 13, 2022

Depending on the type of product or study scope, there are three main approaches for E&L evaluations (the approach selected depends on the purpose or application, and the FDA branch the submission falls under): Pharmaceutical Containers Closure Systems: involves compliance with USP <661.2>, > umbrella).

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

MARCH 17, 2021

Overall, patient compliance for PROs was greater than 90 percent. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. These analyses continue to reaffirm our confidence in abemaciclib, and its potential to make a difference for those with high risk early breast cancer.”

HR 52

HR Trials In-Vitro Manufacturing 52

pharmaphorum

MARCH 4, 2021

Health systems are looking for ways to increasing patient satisfaction while improving patient throughput and compliance in diagnostic imaging,” said Werner Satter, Philips’ general manager, healthcare experience solutions.

Compliance 132

Compliance Clinical Research Radiology Development 132

XTalks

SEPTEMBER 11, 2024

Collaborating with investigators and regulatory authorities ensures compliance with local and international guidelines, fostering transparency and trust. Evaluating potential study sites requires a rigorous assessment of infrastructure, including facilities, equipment and capabilities, to support the study protocol’s requirements.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Hormones 103

Advarra

OCTOBER 31, 2024

Procedure costs: electrocardiograms (ECGs), blood draws, IV infusions, radiology, ophthalmology, and other specialized assessments. Regulatory costs: fees for institutional review board (IRB) approvals, data privacy compliance, and audits. Plan for the future by ensuring you are taking the overall study timeline into consideration.

Research 52

Research Trials Compliance Radiology 52

FDA Law Blog

FEBRUARY 20, 2025

Citing the May 6 compliance date for Stage 1 of the LDT Rule, both ACLA and AMP asked that Judge Jordan issue his ruling expeditiously. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

In-Vitro 102

In-Vitro Regulation Compliance Radiology 102