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

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

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

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

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

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

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

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