MedCity News

JUNE 16, 2023

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York. This system fills that void for both surgeons and patients.”

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Legacy MEDSearch

MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”

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Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Legacy MEDSearch

DECEMBER 7, 2022

Food and Drug Administration market clearance for the ArthroFree System. This was followed by additional partnerships with Hospital for Special Surgery (HSS) in New York, University Hospitals of Cleveland, and LG Electronics USA.”. “We The company hit an important milestone in March 2022 when it received U.S.

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Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. It essentially offered an assessment of risk that would initially be available to care-planning clinicians.

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Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc. Dr. Itatani, MD, Ph.D.,

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Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

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Evolve Your Success

MAY 17, 2022

Antra and Karen started a company and have a podcast where they speak about patient advocacy, impacting how nurses receive an education. Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2. You know when they are trying to push a drug and white-knuckling it.

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Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. We know that going wireless will have the greatest impact for our littlest patients.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.

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Clarify Health

NOVEMBER 21, 2022

Earlier this year, Clarify Health began offering a new service ( Clarify Trials ) whereby companies could receive a list of the most-ideal sites for studies tied to the characteristics of patients they hope to enroll. It essentially offered an assessment of risk that would initially be available to care-planning clinicians.

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Legacy MEDSearch

OCTOBER 27, 2023

an innovator in the field of orthopedic surgical robots, today announced that its TMINI Miniature Robotic System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. THINK Surgical, Inc., ” About THINK Surgical, Inc.

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European Pharmaceutical Review

FEBRUARY 24, 2023

Not only can impurities lead to adverse effects in patients, but they can also introduce product variability. The risks linked to contamination have led regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to implement strict requirements on process characterisation and validation.

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Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Pharmaceutical Technology

JUNE 5, 2023

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

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Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers. Most patients must use a wheelchair by the time they are in their teens.

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Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.

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Pharmaceutical Technology

MAY 17, 2023

To ensure wide access to eligible patients, we are excited to partner with the IDEOGEN Group, a company focused on the commercialisation of speciality medicines for rare diseases across Europe.” In 2010, the US Food and Drug Administration approved Glassia for the same indication.

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Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. So, here they are: 1.

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Legacy MEDSearch

JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Co-founded by Dr. Jihad Mustapha and Dr. Fadi Saab, ACV Centers has a special concentration on treating peripheral artery disease and the complications of critical limb ischemia. Cardio Flow, Inc.,

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Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. So, here they are: 1.

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Evolve Your Success

FEBRUARY 7, 2023

The CE experience for this Podcast is powered by CMEfy – click here to reflect and earn credits: [link] — Watch the episode here Listen to the podcast here Cardiovascular Medical Device Sales With Marc Toth In this episode, we have with us another special guest and he goes by the name of Marc Toth. Patients have a lower copay.

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Pharma Marketing Network

JUNE 11, 2020

You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. They would write up the presentations by physicians about drugs. So, I didn’t look so bad. So, I was actually presenting there.

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pharmaphorum

NOVEMBER 16, 2022

The protocol is a special trading arrangement that allows goods to be transported across the Irish land border without the need for checks, in the same way as they did when the UK was part of the EU customs union. “The warning presented by Teva UK is stark,” according to Cameron.

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Cadensee

JULY 20, 2021

He is one of the first advocates for patient centric health care more than a decade ago when patient opinions and requests were not part of the equation in the system. Uri founded and continues to contribute insights through his digital magazine, e-Pochonder and is one of the first advocates for patient centric health care.

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Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. In May 2022, Perrigo , a company that specializes in OTC health and wellness products completed an acquisition of HRA Pharma.

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World of DTC Marketing

AUGUST 25, 2020

That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. I spent a lot of time in my career working with and talking to clinical scientists about the “drug approval process” The more questions I asked the more I learned. Dr. Stephen Hahn, the F.D.A.’s

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