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?

Food and Drug Administration 110

Food and Drug Administration Food Medical Medicine 110

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Food and Drug Administration 105

Food and Drug Administration FDA Food Training 105

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.

Food and Drug Administration 119

Food and Drug Administration FDA Medical Insurance 119

Infuse Medical

JANUARY 9, 2020

Medical device products require approval by the Food and Drug Administration (FDA) before they go to market. With a product launch plan set in place, you will be able to create marketing collateral, train your sales reps, and cover anything else needed. Educate & Train Your Sales Force. Track Results.

Training 130

Training Food and Drug Administration Sales Marketing 130

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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Food and Drug Administration Government Pharma Healthcare 98

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

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

European Pharmaceutical Review

NOVEMBER 21, 2024

The LAL reagents included in the cartridges are licensed by the US Food and Drug Administration (FDA). Are LAL and rCR cartridges licensed by the FDA? However, recombinant reagents, including both rFC and rCR, are not currently licensed.

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Food and Drug Administration Manufacturing FDA Pharmaceutical manufacturing 52

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

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

European Pharmaceutical Review

DECEMBER 30, 2024

Training the automation workforce However, the full benefits of these technologies can only be realised if there is a workforce with the specialist skills needed to produce, operate and maintain digital and automation tools. Internet] US Food and Drug Administration. Internet] Cell and Gene Therapy Catapult.

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Manufacturing Food and Drug Administration Medicine Training 52

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

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.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Hyperfine, Inc., The Swoop® system received initial U.S.

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Food and Drug Administration FDA Recruitment Food 98

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

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Food and Drug Administration FDA Medical Food 105

Medico Reach

JULY 3, 2022

Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. Meanwhile, you can prepare promotions, train sales personnel, and handle other jobs. Train Your Staff. Employee training is a critical component of any launch strategy.

Medical 97

Medical Food and Drug Administration Training Marketing 97

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.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

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Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

PM360

NOVEMBER 21, 2024

Food and Drug Administration. In 2023, they piloted a cross-cultural agility course and provided unconscious bias training to over 115 hiring managers in their manufacturing plants. This training equips managers with tools to make informed, unbiased hiring decisions.

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Food and Drug Administration Medical Training Management 52

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

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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Patients Food and Drug Administration Medicine Pharma 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. The technology identifies.

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Marketing Food and Drug Administration Pharma Doctors 52

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

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Pharma Food and Drug Administration Medicine Pharmaceutical 98

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

European Pharmaceutical Review

NOVEMBER 15, 2022

Tailoring system training around the routine tasks of the different system user types, ensuring that each user type is given training centered on their tasks and responsibilities. Charlie Wakeham currently serves as Secretary of ISPE GAMP Global Council and on the GAMP Global CSA SIG Leadership Team.

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Manufacturing Pharma Food and Drug Administration Safety 98

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

Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

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Sales Pharmaceutical Ethics Pharmaceutical Sales 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

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

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.

Management 52

Management FDA Food and Drug Administration Physicians 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.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

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Medical sales Medical Sales Patients 130

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.

FDA 52

FDA Food and Drug Administration Recruitment Management 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.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

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