Worldwide Clinical Trials

JULY 8, 2024

It also oversees Good Manufacturing Practices (GMP) for radiopharmaceutical production facilities to ensure consistent quality and safety standards. International Commission on Radiological Protection (ICRP) The ICRP provides recommendations and guidance on radiation protection standards for occupational and public exposure.

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XTalks

OCTOBER 1, 2024

Indicated for patients with known or suspected CAD, Flyrcado’s ready-to-use unit dose can be manufactured offsite and could increase access, especially for patients with imaging challenges, such as those with a high body mass index (BMI) or women.

FDA Approval 105

FDA Approval Drugs Manufacturing Production 105

Pharma Packaging Solutions

OCTOBER 29, 2024

Navigating the Regulatory Landscape In the United States, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) lays down strict regulations that govern medical device packaging. International Standards and Classifications Compliance doesn’t end with the EU GMP certifications.

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Packaging Packaging Regulation Pharma Packaging 52

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

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.

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Containment Radiology Cosmetics Manufacturing 52

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). It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market.

Radiology 40

Radiology Production Regulation Manufacturing 40

XTalks

APRIL 19, 2024

Validated across 381 CT scans using 39 different scanner models from five leading manufacturers, Avicenna.AI’s pulmonary embolism detection tool CINA-iPE demonstrated high sensitivity and specificity in the validations, highlighting its effectiveness across various clinical settings.

Marketing 52

Marketing Radiology Development Manufacturing 52

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. By Jeffrey K. Shapiro & Allyson B. Gone are the days of tool type indications for this type of device.

Regulation 52

Regulation Medicine Radiology Cosmetics 52

Intouch Solutions

JUNE 30, 2022

If major pharmacies like CVS are planning for the metaverse, pharma manufacturers should be fast followers! Their focus is on nutrition, wellness, and counseling, which may signal the desire to become a virtual healthcare provider. Early Healthcare Innovators in VR and Blockchain. How does EaseVRx’s virtual reality system treat back pain?

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

The Pharma Data

DECEMBER 23, 2020

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). It will be funded by the U.S. About INO-4800.

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DNA Vaccination Vaccine Immune Response 40

FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

The Pharma Data

MAY 16, 2021

Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine. Department of Health and Human Services in collaboration with the U.S.

Immune Response 52

Immune Response Vaccination Vaccine Trials 52

XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. a specialist in developing and manufacturing universally implantable biotechnologically produced human tissue.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Roots Analysis

JANUARY 17, 2024

Further, prefilled syringes are being manufactured in different capacities, based on the requirements of stakeholder / end users in this domain. However, these syringes are associated with certain limitations, such as fragile nature, leaching of extractables, high manufacturing cost and heavy weight.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

XTalks

MAY 13, 2022

Manufacturers must conduct various tests such as stability and extractables and leachables (E&L) testing for packaging materials and enclosures to meet safety and efficacy guidelines. Manufacturing (MFG) Systems/Component/Processes: can ideally involve a USP approach, or a BPOG (BioPhorum Operations Group) approach.

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

OCTOBER 22, 2020

The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply. 94% on room air, and radiological evidence of pneumonia. Moderate COVID-19 was defined as confirmed SARS-CoV-2 infection, SpO2 >94% and radiological evidence of pneumonia.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

Delveinsight

JANUARY 14, 2021

PROstep Minimally-Invasive Foot and Ankle system and MICA are manufactured, keeping in mind all the “current” procedures that can be performed through a smaller, minimally invasive, incision, with a focus on preserving the soft tissues. The company has developed PROstep that is a minimally invasive surgical (MIS) technique.

Marketing 40

Marketing Radiology Development Production 40

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Fourth, the inability to manage this influx will harm the diagnostic industry, including manufacturers of distributed IVD products. 360(m)(a)(3). [16]

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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. software or labeling.

Regulation 52

Regulation In-Vitro Development Radiology 52

Intouch Solutions

SEPTEMBER 27, 2024

Manufacturers of drugs and diagnostics have to create a plan for their products/therapies to become part of an algorithm and to have AI adopters on staff or as consultants as the space continues to broaden. Treatment sequencing remains one of the bigger challenges in the oncology landscape.

DNA 59

DNA Trials Antibody Marketing 59

The Pharma Data

JANUARY 19, 2021

million in Serenno Medical and will also manufacture Serenno’s urine output monitoring device for early detection and prevention of acute kidney injury. Elcam is a global company with manufacturing facilities in Israel and Italy and representation within the US, Europe , China , Japan and South America. YOKNEAM, Israel , Jan.

Manufacturing 52

Manufacturing Production Radiology Cardiology 52

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

MARCH 10, 2021

Cue Health is planning to manufacture more than 100,000 tests per day by the summer. The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in a press announcement from the agency.

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Protein RNA Antibody Production 98

Delveinsight

DECEMBER 29, 2020

Teleflex Incorporated has finally completed the acquisition of Z-Medica, an industry-leading manufacturer of hemostatic products. Teleflex is a global manufacturer of medical technologies and equipment aiming to add value to the healthcare and pharmaceutical industry.

Trials 52

Trials Drugs Hormones Radiology 52

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We In response to the recall, the FDA lately conducted an examination of a Philips Respironics’ manufacturing installation to determine what may have caused or contributed to the froth issues and assess adherence to the agency’s conditions for quality manufacturing.

Cosmetics 40

Cosmetics Compliance Production Manufacturing 40

The Pharma Data

NOVEMBER 17, 2020

director of FDA’s Center for Devices and Radiological Health. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

Radiology 40

Radiology Cosmetics Production Doctors 40

The Pharma Data

MARCH 17, 2021

Verzenio is Lilly’s first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology. INDICATION.

HR 52

HR Trials In-Vitro Manufacturing 52

The Pharma Data

MARCH 24, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

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Vaccination Vaccine Radiology Trials 52

The Pharma Data

MARCH 22, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

Trials 52

Trials Vaccination Vaccine Radiology 52

The Pharma Data

APRIL 7, 2023

The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations.(5)

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FDA Approval Drugs Medicine Genetics 40

The Pharma Data

NOVEMBER 9, 2021

This procurement of molnupiravir will be supported in whole with civil finances from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological (..)

Medicine 52

Medicine Radiology Development Drugs 52

The Pharma Data

NOVEMBER 20, 2020

While Lucira ramps up manufacturing of the test, it will only be available on a limited basis in point-of-care settings and healthcare networks that prescribe the test for patients to use at home, the company said. . The test will cost about $50.

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Vaccination Vaccine Genetics Radiology 52

The Pharma Data

NOVEMBER 18, 2020

While Lucira ramps up manufacturing of the test, it will only be available on a limited basis in point-of-care settings and healthcare networks that prescribe the test for patients to use at home, the company said. . The test will cost about $50.

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FDA Approval Vaccination Vaccine Genetics 52

The Pharma Data

MAY 3, 2021

India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions ( MedtechDive ). Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions ( MedtechDive ). Coronavirus Pandemic.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52

FDA Law Blog

FEBRUARY 20, 2025

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. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.)

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XTalks

SEPTEMBER 14, 2020

In April alone, food and accommodation services had dropped by a good 42 percent, manufacturing followed with a 22.5 Meanwhile, researchers at the University of Toronto are developing synthetic therapeutic antibodies that they say are more potent than naturally occurring antibodies and which can be readily manufactured in large quantities.

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