Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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Food and Drug Administration FDA Recruitment Food 98

PM360

OCTOBER 25, 2023

Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. Similarly, major pharmaceutical companies are not likely to up their engagement in cannabis drug development. On August 30, the U.S.

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Food and Drug Administration FDA Medical Insurance 119

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training.

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Food and Drug Administration Medicine Training Electronics 98

Infuse Medical

JANUARY 9, 2020

Plan Ahead Before FDA Approval. Medical device products require approval by the Food and Drug Administration (FDA) before they go to market. With an unpredictable FDA timeline, the launch date could come sooner than you think. We recommend creating a plan with deadlines before FDA approval.

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European Pharmaceutical Review

DECEMBER 18, 2023

Psilocybin-assisted therapy Psilocybin-assisted therapy combines psilocybin with psychological support from trained therapists. Classified as a Schedule I drug—defined as having no accepted medical use and a high potential for abuse— psilocybin is currently not approved by the US Food and Drug Administration (FDA) for clinical use.

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Food and Drug Administration Patients Side effects Safety 116

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. a medical device subject to FDA oversight and enforcement.

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Food and Drug Administration FDA Medical Food 105

Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Food and Drug Administration Physicians Medical Prescription 111

Medico Reach

JULY 3, 2022

Begin Preparation Before FDA Approval. Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. The launch date may be closer than you believe with the FDA’s unpredictable timeframe. Train Your Staff. Create a Marketing Plan.

Medical 97

Medical Food and Drug Administration Training Marketing 97

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

JANUARY 19, 2023

The Winn Award Program has so far trained 114 early-stage investigator physicians. Currently close to 80 percent of participants in clinical research trials are white, according to the Food and Drug Administration (FDA). Diversity in clinical trials Diversity in clinical trials is a longstanding challenge.

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Food and Drug Administration Physicians Medicine Food 98

Legacy MEDSearch

MARCH 22, 2023

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. Measurement interpretation has been expanded to all physicians with appropriate training. Are you hiring?

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Management FDA Food and Drug Administration Physicians 52

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

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Legacy MEDSearch

NOVEMBER 1, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node 1 , an AI application used to detect breast cancer metastases in lymph node tissue. Paige Lymph Node is the first AI application of its kind to receive Breakthrough Device Designation from the FDA. Are you hiring?

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FDA Food and Drug Administration Recruitment Management 52

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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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

European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. Additionally, the Phase IIb trial found that outcome was associated with dose. About the author.

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Food and Drug Administration Healthcare Healthcare Food 69

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Training and education. This involves providing continuous training and education to all employees at every level.

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Government Pharma Training Ethics 98

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

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Are you hiring?

FDA 52

FDA Food and Drug Administration Physicians Safety 52

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Nixon Gwilt Law

APRIL 22, 2024

If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Generative AI companies require immense and continuous amounts of data to train their models. When does it apply? What can I do to comply?

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 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

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Nixon Gwilt Law

APRIL 22, 2024

If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Generative AI companies require immense and continuous amounts of data to train their models. When does it apply? What can I do to comply?

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

European Pharmaceutical Review

MARCH 8, 2023

Ekaterina received her medical degree from St Petersburg Medical Academy in St Petersburg, Russia, and then moved to the US where she completed her Internal Medicine residency training. I am a physician by training, and I worked in New York hospital emergency rooms for many years. I believe we can and must do better.

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Leads Pharma Food and Drug Administration Medicine 52

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

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Food and Drug Administration FDA Patients Insurance 52

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Food and Drug Administration Prescription Media Patients 105

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.

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Food and Drug Administration Recruitment FDA Patients 52

Rep-Lite

SEPTEMBER 21, 2024

It’s like having a playbook—everyone knows their position, boosting performance and making sales training more effective. Training and Onboarding New Sales Representatives A comprehensive medical sales training program is key to equipping new hires with the right product knowledge and sales tactics.

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Medical sales Sales Medical Medical sales reps 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

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Food and Drug Administration Engineering Patients Education 59

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Pharma Marketing Network

OCTOBER 3, 2024

Marketers must adhere to regulations set forth by bodies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. This includes implementing comprehensive training programs for marketing teams to ensure they are well-versed in regulatory guidelines.

Marketing 52

Marketing Pharmaceutical Healthcare Healthcare 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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Food and Drug Administration Side effects Pharmaceutical Leads 115

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years?

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Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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