pharmaphorum

MAY 18, 2022

” He was also involved in the creation of the FDA’s Digital Health Center of Excellence in 2020 and drawing up the Center for Devices and Radiological Health (CDRH) 2022-2025 strategic priorities, which covers much of the agency’s digital health plans.

Radiology 139

Radiology Regulation Production Drugs 139

Scienmag

FEBRUARY 16, 2021

Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community” A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical […].

Radiology 48

Radiology Drugs Clinical Trials Clinical Trials 48

pharmaphorum

SEPTEMBER 14, 2021

In the European hospital setting, the first to digitise were the picture archiving systems (PACS) in radiology departments then electronic medical records (EMRs), patient administration systems and departmental IT flow work solutions (eg, laboratory information systems and radiology information systems).

Radiology 135

Radiology Clinical Trials Clinical Trials Pharmacy 135

pharmaphorum

JUNE 13, 2022

It aimed to make genomics part of routine healthcare in the NHS, create a genomics data resource and stimulate partnerships with biopharma companies on drug discovery projects, and is still generating new findings for participants. ” The post Genomics England will move HQ to Canary Wharf’s new biocluster appeared first on.

Genomics 111

Genomics Genome Life Science Genome Project 111

Scienmag

JANUARY 14, 2021

Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is […]. Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development TUCSON, Ariz.,

Radiology 44

Radiology Development Drugs Scientist 44

FDA Law Blog

JULY 17, 2024

Peter Marks and Patrizia Cavazzoni, spans across both Centers, and will collaborate with the Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.

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Production Genetics Development Drugs 105

BioTech 365

OCTOBER 9, 2020

Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDHR) at the Food and Drug Administration (FDA), and Dr. Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the … Continue reading →

Life Science 40

Life Science Radiology Drugs Research 40

Advarra

MARCH 6, 2025

The Value of Clinical Research Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients access to treatment options, improve patient care and outcomes, and transform the healthcare landscape.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

MAY 24, 2022

What I like about my role at Worldwide Clinical Trials is that feeling that I am close to the patient, as I am often involved in confirming the patient’s eligibility on the study, understanding how patients are responding to the drug. Every patient is precious on these studies.

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Clinical Trials Clinical Trials Research Trials 130

The Pharma Data

FEBRUARY 21, 2022

We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Re-imagining Radiology. In particular, AI bears vast potential for advancing radiology.

Radiology 52

Radiology Cardiology Development Production 52

XTalks

SEPTEMBER 9, 2022

This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode.

Radiology 98

Radiology Life Science Licensing Licensing 98

XTalks

MARCH 27, 2023

Cidara Therapeutics and Melinta Therapeutics recently announced that Rezzayo (rezafungin for injection) has been approved by the US Food and Drug Administration (FDA). Echinocandins offer a number of advantages to other antifungal medications including fewer drug-drug interactions, unique mechanism of action and fewer AEs.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

XTalks

MAY 21, 2024

This year’s event was particularly momentous, with a noteworthy announcement from the US Food and Drug Administration (FDA) about the extensive ongoing efforts to innovate clinical trials. The FDA’s message emphasized the crucial advancements in science and technology that are propelling medicine forward.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Clinical Research 64

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). billion in 2018 and is projected to reach $9.84 percent.

RNA 97

RNA In-Vitro Genotype Marketing 97

Delveinsight

DECEMBER 29, 2020

However, for geographies other than the US and Canada, Pfizer has received an exclusive right to develop the drug in oncology except in certain Asian countries. Welcome the First Generic of Drug for Severe Hypoglycemia. mg and norethindrone acetate (0.5 mg) in the US and Canada. Audentes Therapeutics’ ASPIRO Trial Free to Proceed.

Trials 52

Trials Drugs Hormones Radiology 52

Worldwide Clinical Trials

JULY 8, 2024

In your pharmaceutical drug development program, it’s critical to carefully consider your ideal target population and implement specific inclusion criteria to maximize patient safety. Tissue Sensitivity : The sensitivity of target tissues and nearby organs to radiation therapy can vary considerably.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

XTalks

OCTOBER 6, 2021

The US Food and Drug Administration (FDA) gave clearance to Siemens Healthineers’ new photon-counting scanner computed tomography (CT) last week, making it the first significant tech advancement in the field in almost a decade. The scanner is called the Simens Naeotom Alpha.

FDA Approval 98

FDA Approval Radiology Research Development 98

XTalks

JANUARY 26, 2024

Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs. CRISPR/Cas9 offers a pathway to potentially overcome this, by modifying genes that are responsible for drug resistance in cancer cells.

Research 118

Research Gene Editing Gene Genetics 118

XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

JUNE 30, 2023

Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM).

FDA Approval 98

FDA Approval Radiology Trials Life Science 98

pharmaphorum

MARCH 31, 2021

Novartis has been steadily building itself into a radio-oncology powerhouse in the last few years, seeing the category as one of four pillars of its cancer business, along with cell and gene therapy, targeted drugs and immunotherapeutics. Novartis licenses the drug from Genmab and reformulated into its Sensoready autoinjector pen.

Licensing 98

Licensing Licensing Gene Therapy Sales 98

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

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

The Pharma Data

DECEMBER 15, 2020

Food and Drug Administration. director of the FDA Center for Devices and Radiological Health, “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. TUESDAY, Dec. Results are delivered by smartphone in as little as 20 minutes. According to Jeffrey Shuren, M.D.,

FDA Approval 52

FDA Approval Radiology Protein Drugs 52

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.

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Production Radiology Marketing Development 98

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration on Wednesday. “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release.

Packaging 52

Packaging Packaging Radiology Drugs 52

FDA Law Blog

AUGUST 18, 2024

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

In-Vitro 69

In-Vitro Radiology Cosmetics Medicine 69

FDA Law Blog

FEBRUARY 20, 2023

Among its services are prescription drug discounts, telehealth visits, and other health services. Through our FDA-focused lens, we see a possible roadmap as FDA’s Center for Devices and Radiological Health (CDRH) increases its resources, guidances, and enforcement emphases in the connected digital device space.

Radiology 105

Radiology Regulation Compliance Marketing 105

XTalks

APRIL 27, 2021

The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older.

Radiology 105

Radiology Development FDA Approval Containment 105

The Pharma Data

SEPTEMBER 30, 2021

Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body). Today, the U.S.

Radiology 52

Radiology In-Vitro Marketing Drugs 52

Delveinsight

SEPTEMBER 27, 2021

It can be due to the previous existence of brain damage signs (psychomotor retardation, neurologic signs, radiologic signs, or other types of seizures) or on the basis of etiology that is characterized by a lack of previous signs of brain damage. There are many different causes of epileptic spasms.

Marketing 77

Marketing Hormones Radiology Pharma Companies 77

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. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.

Compliance 52

Compliance Trials Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 10, 2020

It could be used to predict potential changes in efficacy down the line, for example if a mutation appears at scale in the virus that would be in the target region of an antiviral drug. Controlling this virus means understanding it at new levels that go beyond simple testing,” commented Jurgi Camblong, Sophia Genetics’ founder and CEO.

Genetics 136

Genetics Genomics Genome Vaccine 136

The Pharma Data

MARCH 24, 2021

The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks. These results have been presented to the independent Data Safety Monitoring Board. JPEO-CBRND.

Vaccination 52

Vaccination Vaccine Radiology Trials 52

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.,

Production 69

Production Regulation Radiology Development 69

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.

Packaging 52

Packaging Packaging Regulation Pharma Packaging 52

XTalks

SEPTEMBER 5, 2024

The trials, published in Radiology , involved 44 patients and 49 tumors — ranging from primary liver cancers to metastatic tumors. After receiving US Food and Drug Administration (FDA) De Novo clearance , the Edison Histotripsy System rapidly transitioned from trials to real-world use.

Trials 52

Trials Radiology Compliance Production 52