European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

Pharmaceutical 98

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PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. From the manufacturer perspective, payer policies and legislation on combination therapy pricing are impacting global development, pricing, access, and commercialization strategies.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Engineering Pharmacology 97

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. About NeuroLogica. NeuroLogica Corp., NeuroLogica Corp.,

FDA 92

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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 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Medicine Pharma 105

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

Medical 98

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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

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 105

Food and Drug Administration Medicine Safety Consulting 105

Legacy MEDSearch

DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC. The Quantra System’s easy and fast interpretation enables simple, more efficient point-of-care bleeding management.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

European Pharmaceutical Review

DECEMBER 30, 2024

It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000. 1 It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000.

Manufacturing 52

Manufacturing Food and Drug Administration Medicine Training 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 98

Pharma Food and Drug Administration Medicine Pharmaceutical 98

Legacy MEDSearch

OCTOBER 27, 2023

Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. FDA in April 2023 for use with an implant from a single implant manufacturer. THINK Surgical, Inc., THINK Surgical is committed to an open implant library. THINK Surgical, Inc., is a privately held U.S.-based

Specialization 52

Specialization FDA Food and Drug Administration Recruitment 52

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 98

Government Pharma Training Ethics 98

Medico Reach

JULY 3, 2022

Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. Sales, marketing, training, customer service, manufacturing, quality, and regulatory departments all play a crucial role in a product launch. Begin Preparation Before FDA Approval.

Medical 97

Medical Food and Drug Administration Training Marketing 97

Legacy MEDSearch

MARCH 2, 2023

Apyx Medical Corporation (NASDAQ:APYX) , the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion ® , today announced it has received 510(k) clearance from the U.S. Renuvion ® and J-Plasma ® offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

DECEMBER 16, 2022

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Manufacturing 52

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). ” CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

MAY 30, 2023

Food and Drug Administration (FDA). It’s been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success,” said Duncan Smith, managing partner of Sagentia Innovation. THINK Surgical, Inc., About THINK Surgical, Inc.

FDA 52

FDA Food and Drug Administration Recruitment Consulting 52

Legacy MEDSearch

JULY 14, 2023

Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. In addition, AceConnex Pre-Sutured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured pre-operatively.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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

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

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. Drug Approvals. FDA Update.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

OCTOBER 3, 2023

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

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. 2019;17(11):1309-1316.

Food and Drug Administration 52

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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.

Patients 52

Patients FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Marketing 52

Marketing FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

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

Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. The regulatory clearance of the EyeArt v2.2.0

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

Legacy MEDSearch

MAY 18, 2023

Food and Drug Administration has granted the Connexus DDI “Breakthrough Device Designation”, which offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions. In addition to the funding, Paradromics announced that the U.S.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process.

FDA 52

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Legacy MEDSearch

AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

Food and Drug Administration 52

Food and Drug Administration Management Medical Recruitment 52

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