Legacy MEDSearch

JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

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. Blockchain technology creates a decentralised and unalterable ledger that records all transactions across a network of computers.

Government 84

Government Pharma Ethics Training 84

Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

APRIL 12, 2023

Additional development efforts of its proprietary technology platform are underway for tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of growth factors, anti-infective agents, and local anesthetic drugs.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

PM360

AUGUST 9, 2022

When asked about driving diversity in clinical trials, 31% of surveyed oncologists felt the best solution is to create a network of clinical trial sites in underserved communities. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. DC Dispatch: PFAS Are More Harmful Than Originally Stated.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

MAY 18, 2023

the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. We invest in early-stage companies reinventing human augmentation, energy, transportation, infrastructure, manufacturing, and agriculture. Paradromics Inc.,

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. It would be expected that with accuracies similar to invasive alternatives, system-wide use would almost certainly lead to resource savings while simultaneously improving outcomes for patients with heart failure.”

Food and Drug Administration 52

Food and Drug Administration Management Recruitment Medical 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. C-limit and be applied to the whole supply chain.

Pharma 77

Pharma Food and Drug Administration Medicine Pharmaceutical 77

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. 2] Figure 1.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Medico Reach

JULY 3, 2022

Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. That may frequently lead your team to race to complete all necessary tasks before the product’s debut. Begin Preparation Before FDA Approval. Measurable goals and objectives help direct your actions.

Medical 97

Medical Food and Drug Administration Training Marketing 97

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. surgeries of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.-based Individual results may vary.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Pharmaceutical 124

Pharmaceutical Food and Drug Administration Manufacturing FDA 124

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. For more information, please visit www.vivasuremedical.com.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Legacy MEDSearch

SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. Altus Capital Partners is a private equity firm that controls investments in middle-market manufacturing businesses. For more information, please visit www.choicespine.com.

Food and Drug Administration 52

Food and Drug Administration Recruitment Marketing Management 52

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. 2 Yet according to a 2022 report by GlobalData, it is difficult to achieve high quality and highly pure mRNA via scalable manufacturing.

Food and Drug Administration 86

Food and Drug Administration Medicine Safety Consulting 86

Legacy MEDSearch

NOVEMBER 15, 2022

Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

Pharmaceutical Technology

JUNE 30, 2022

This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”. Bolkvadze predicts that another challenge may be found in the increased volume of operations, leading to a capacity shortage.

Food and Drug Administration 52

Food and Drug Administration Distribution Recruitment Transportation 52

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.

Media 52

Media Pharma Ethics Consulting 52