European Pharmaceutical Review

JANUARY 26, 2023

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.

Food and Drug Administration 90

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 90

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Pharmaceutical products 52

European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 78

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 78

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.

Food and Drug Administration 76

Food and Drug Administration Pharmaceutical products Pharmacology FDA 76

Pharmaceutical Technology

DECEMBER 14, 2022

Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration Pharmaceutical products FDA Marketing 59

Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

Healthcare 40

Healthcare Healthcare Marketing Pharma 40

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

European Pharmaceutical Review

APRIL 21, 2023

Yet the pharmaceutical sector is just starting that journey; one that will be impacted substantially by consequences of the climate crisis – from heatwaves to new infectious diseases, to longer hay fever seasons and new allergies. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

Pharma 83

Pharma Food and Drug Administration Medicine Pharmaceutical 83

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. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?

Government 90

Government Pharma Ethics Training 90

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

Pharmaceutical 127

Pharmaceutical Food and Drug Administration Manufacturing FDA 127

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. Why the use of RFID has fluctuated over the past decade?

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Food and Drug Administration Electronics Pharma FDA 105

European Pharmaceutical Review

AUGUST 9, 2022

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

Food and Drug Administration 85

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 85

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand.

Manufacturing 85

Manufacturing Food and Drug Administration Patients Pharma 85

Cadensee

JULY 20, 2021

head of digital engagement and capabilities, teva pharmaceuticals. Uri Goren is the head of digital engagement and capabilities at Teva Pharmaceuticals, and just recently became a member of the National Advisory Board for digital health for the Israel Ministry of Health. Show Notes.

Food and Drug Administration 52

Food and Drug Administration Doctors Healthcare Healthcare 52

World of DTC Marketing

SEPTEMBER 28, 2020

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

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Food and Drug Administration Pharma Side effects Food 163

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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Manufacturing Medical Food and Drug Administration Pharmaceutical 52