Pharmaceutical Commerce

FEBRUARY 15, 2024

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

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FDA Safety Manufacturing Pharmaceutical 52

Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. home health visits). the patient population, product being studied, therapeutic area, and trial phase.

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eMediWrite

JULY 13, 2023

They play a crucial role in assuring the efficacy and safety of products given to patients. Laboratory Information Management Systems (LIMS), tailored to the needs of pharmaceutical manufacturing and quality assurance/quality control (QA/QC) laboratories, are proving to be a powerful force in enabling the industry to meet these challenges.

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Pharmaceutical products Safety Pharmaceutical Pharmaceutical manufacturing 52

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Doing so means that businesses can check their compliance before an FDA inspection.

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European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

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Medical Food and Drug Administration Manufacturing Safety 92

European Pharmaceutical Review

JANUARY 16, 2023

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The FDA already has a MRA in place with the European Union (EU) and one with the UK.

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Food and Drug Administration FDA Manufacturing Food 110

Pharma Leaders

MAY 1, 2023

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The FDA also did not request for new preclinical or Phase III clinical trials for assessing efficacy or safety.

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). The company stated that the Phase I/IIa trial will thoroughly evaluate the therapy’s clinical efficacy and safety.

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Food and Drug Administration FDA Food Safety 59

World of DTC Marketing

APRIL 12, 2021

We need a 21st-century approach that puts patient safety first. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety. Can patients really be confident in pharma supply chains?

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Food and Drug Administration Prescription Pharma Manufacturing 187

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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Food and Drug Administration Medicine FDA Food 91

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Manufacturing Food and Drug Administration FDA Marketing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 86

Pharmaceutical Technology

JUNE 24, 2022

The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA. The vaccine showed an encouraging safety and tolerability profile in both trials. The post Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults appeared first on Pharmaceutical Technology.

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Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Press Release by: Hip Innovation Technology. Are you hiring?

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FDA Safety Recruitment Patients 98

European Pharmaceutical Review

FEBRUARY 19, 2024

Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER) stated that Amtagvi is a novel T cell immunotherapy for patients with limited treatment options. FDA highlighted that among the 73 patients treated with Amtagvi at the recommended dose: Objective response rate was 31.5 percent, 47.8

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Food and Drug Administration FDA Manufacturing Food 73

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. .” Cresilon’s mission is to save lives.

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FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

APRIL 25, 2023

Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months. Professor Hill added that the “partnership with the [vaccine’s manufacturer] has been key to successful very large-scale manufacturing and rapid development.”

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Manufacturing Safety Food Medicine 108

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 1-adapted vaccine.

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European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

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pharmaphorum

AUGUST 31, 2022

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 The FDA said in a statement that the BA.4 The post FDA clears bivalent Omicron shots from Pfizer, Moderna appeared first on.

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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. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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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. Are you hiring? Contact us to discuss partnering with Legacy MedSearch on your position.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Observers expect this will allow mass-scale manufacturing at modest cost, thereby turning the tide against malaria.

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Manufacturing FDA Food Safety 111

European Pharmaceutical Review

DECEMBER 13, 2022

The World Health Organization (WHO) linked this recent incident to an Indian manufacturer, saying that the cough syrups contained “unacceptable amounts of diethylene glycol and ethylene glycol”. This was also the first step on the road towards universal adoption of good manufacturing practice (GMP).

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Food and Drug Administration Manufacturing Safety Food 94

Nixon Gwilt Law

JULY 18, 2023

The TCET pathway is limited to novel medical devices and device-led combination products with FDA-designated Breakthrough Device status awaiting full FDA approval. While potentially a fast path to coverage on an individual basis, this determination process creates the most inconsistency for manufacturers and individuals alike.

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World of DTC Marketing

JANUARY 8, 2021

Can the FDA really control the quality of vaccine orders this big? The federal government is negotiating with Pfizer to see how it can help with those manufacturing issues in order to get the additional 100 million doses but under no circumstances should product quality come into question. Supply Issues?

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European Pharmaceutical Review

JUNE 29, 2023

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. Lantidra’s mechanism of action The primary mechanism of action of Lantidra is believed to be the secretion of insulin by the infused allogeneic islet beta cells, FDA stated.

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Food and Drug Administration FDA Food Education 94

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024. months for TEVIMBRA versus 6.3

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Food and Drug Administration Manufacturing Safety Medicine 90

European Pharmaceutical Review

MARCH 28, 2024

A paper published in Applied Sciences has described a quality risk assessment methodology for application in sterile PET radiopharmaceutical production under Good Manufacturing Practice (GMP) regulations. Expanded Pluvicto production gets FDA go-ahead What did the results show?

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Pharmaceutical Technology

APRIL 6, 2023

A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades. If proven and approved, the rapid introduction of AD04 into the U.K.

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European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 7 For example, reducing immunogenicity of the viral vectors and improving manufacturing process and capacity will be vital to the future success of gene therapies.

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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Above all else, manufacturers need to get their houses in order. Tackling shortages. The stakes are high. Logistical challenges.

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Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

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Pharmaceutical Technology

JUNE 30, 2022

This deal might comprise Omicron-adapted Covid-19 vaccines for use in adults, contingent on obtaining the US Food and Drug Administration (FDA) authorisation. Last week, the companies reported findings where two Omicron-adapted vaccine candidates showed safety, tolerability and immunogenicity.

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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