Pharmaceutical Technology

MAY 12, 2023

Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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Food and Drug Administration Pharmaceutical FDA Specialization 52

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. Moximed is based in Fremont, California. Are you hiring?

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Marketing FDA Food and Drug Administration Recruitment 96

Pharmaceutical Technology

SEPTEMBER 29, 2022

A flagship company of the Torrent Group, Torrent Pharmaceuticals is a speciality-focused firm with more than 74% of its revenue from chronic and sub-chronic therapies in India. Among these facilities, four are approved by the US Food and Drug Administration (FDA).

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Food and Drug Administration Pharma Specialization Food 59

Pharmaceutical Technology

OCTOBER 3, 2022

The board of directors of Myovant constituted a special committee of independent directors including its audit committee members to assess the proposal. The special committee decided that the deal substantially undervalues Myovant and is not in the firm’s or its minority shareholders’ best interests.

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Food and Drug Administration Specialization Biopharma Food 52

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. The post FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

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FDA Food and Drug Administration Recruitment Physicians 52

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. ” Pediatric medical innovation remains a challenge. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4%

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Food and Drug Administration Pharma Medicine Distribution 52

Legacy MEDSearch

MARCH 16, 2023

Nurses or technicians can easily perform a bedside measurement and obtain a clear negative or positive output in less than 5 minutes without requiring specialized personnel or complicated equipment. For more information, visit [link]. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

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FDA Patients Food and Drug Administration Recruitment 52

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.

Marketing 52

Marketing Food and Drug Administration Pharma Doctors 52

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.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. How the FDA Classifies Medical Devices. The FDA classifies medical devices into one of three classes based on their risks and regulatory controls: . They are not obligated to submit data or information to the FDA. .

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Medical Marketing Patients Food and Drug Administration 52

PM360

FEBRUARY 12, 2024

Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?

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Food and Drug Administration Patients Medical Networking 105

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. The EMA started a rolling review for this Omicron-adapted vaccine on 27 June and the FDA plans to review the vaccine for EUA. 1 sub-lineage on 19 July.

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Manufacturing Food and Drug Administration Marketing FDA 52

European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

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Manufacturing Pharma Food and Drug Administration Safety 98

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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Food and Drug Administration Education Insurance Healthcare 52

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

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., Are you hiring?

Specialization 52

Specialization FDA Food and Drug Administration Recruitment 52

Pharmaceutical Technology

AUGUST 24, 2022

The importance of ribbon density has previously been emphasized by Helen Winkle [1] from the US Food and Drug Administration (FDA) and it becomes clear then that maintaining the ribbon density by setting the correct force and gap is crucial for the final granulates. References. [1] 2] Gamble, J. et al, Pharmaceut.

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Food and Drug Administration Manufacturing Pharmaceutical Specialization 52

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. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52

Rep-Lite

SEPTEMBER 21, 2024

Key traits to look for in medical sales reps: Strong communication skills Adaptability to changing markets A deep understanding of medical device sales strategies Problem-solving abilities Self-motivation and resilience Recruitment strategies include networking at industry events, leveraging LinkedIn , and working with specialized recruiters.

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Medical sales Sales Medical Medical sales reps 52

European Pharmaceutical Review

FEBRUARY 24, 2023

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. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

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Food and Drug Administration Engineering Specialization Food 98

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. Caldolor has already obtained FDA approval for pre-operative administration.

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Food and Drug Administration FDA Side effects Safety 98

Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The company’s commercial strategy for the therapy includes an extensive patient support programme named RYZUP, which supports and educates those for whom the drug is prescribed and assists with access to the medicine.

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Food and Drug Administration Pharmaceutical Specialization Food 98

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. All diseases are now “rare diseases”.

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

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., Are you hiring?

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Thus, LAMP assays, combined with DNA extraction by boiling, can be used as effective methods to detect BCC strains found in drug ingredients, pharmaceutical-grade water, and finished pharmaceutical products.”.

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Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

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.,

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Food and Drug Administration Physicians Recruitment Medical 97

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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Medical Food and Drug Administration Healthcare Healthcare 98

Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

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.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Pharma Marketing Network

JUNE 11, 2020

Yeah, I even wanted to wear the shirt to this FDA meeting. 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.

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Media Pharma Ethics Consulting 52

Cadensee

JULY 20, 2021

48:12 What is Uri Gorenseeing that is special in the Israeli Digital Health ecosystem? It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? When do you think it is the most important?

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Food and Drug Administration Doctors Healthcare Healthcare 52

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. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

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FDA Food and Drug Administration Prescription Pharma 52

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. scientists. Dr. Stephen Hahn, the F.D.A.’s

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