European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. 1,2 The second occurrence of NDMA arising from degradation was in metformin drug product. Available from: [link] 4. J Pharm Sci.

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Food and Drug Administration Pharmaceutical FDA Medicine 98

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

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Food and Drug Administration FDA Manufacturing Law & Regulation 59

European Pharmaceutical Review

MARCH 7, 2024

Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024. Orano Med is now building industrial facilities throughout the world for the commercialisation its drugs.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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Food and Drug Administration Medicine Pharmaceutical Government 40

World of DTC Marketing

MARCH 17, 2022

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease.

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Food and Drug Administration Medical Patients Ethics 255

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma 122

Pharma Food and Drug Administration Manufacturing Medicine 122

European Pharmaceutical Review

AUGUST 22, 2022

For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. Procedure under Article 5(3) of Regulation EC (No) 726/2004. 2022 [cited 30 July 2022].

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Food and Drug Administration Prescription Food Medicine 59

Cadensee

JULY 20, 2021

When he was going through his cancer, he died in 2004. It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? They found that Tuesday and Friday are better days to start administering or taking their drug.

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Food and Drug Administration Doctors Healthcare Healthcare 52

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

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Pharma Food and Drug Administration Safety Medicine 98