European Pharmaceutical Review

MARCH 1, 2024

Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Food and Drug Administration 59

Food and Drug Administration Manufacturing Pharmaceutical products Food 59

European Pharmaceutical Review

JULY 3, 2025

Future projections In a future state, the need will arise for rapid methods to be available for all types of [microbiological] products” Rapid microbiology has come a long way in recent years. Modernisation will drive objectivity and faster reaction times to quality events, improving the lives and meeting the ongoing needs of patients.

Medicine 69

Medicine Manufacturing Electronics Pharmaceutical manufacturing 69

European Pharmaceutical Review

MARCH 27, 2024

In turn, this impedes growth of the market because of the resulting delay in product approvals. The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor.

Safety 94

Safety Marketing Food and Drug Administration Pharmaceutical 94

Pharmaceutical Technology

MARCH 22, 2023

The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In August of 2022, Fresenius Kabi announced a three-year plan to add GS1 Data Matrix barcodes, also known as 2D barcodes, to its US pharmaceutical portfolio.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma Pharmaceutical products 105

European Pharmaceutical Review

DECEMBER 4, 2023

The result is efficient, cost-effective and high-quality (bio)pharmaceutical production. The most recent advances in PAT and associated technologies are further improving knowledge transfer and accessibility from R&D all the way to full-scale production plants. Enter the era of benchtop NMR solutions.

Pharmaceutical manufacturing 105

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 105

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. References.

Food and Drug Administration 97

Food and Drug Administration Management Manufacturing Pharmaceutical manufacturing 97

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. Nitisinone capsules are hydroxy-phenylpyruvate dioxygenase inhibitors which are used as first-line treatment for a rare condition, hereditary tyrosinemia type 1 (HT-1).

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Pharmaceutical products 52

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 Marketing FDA 59

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 Pharmaceutical products 52

European Pharmaceutical Review

JANUARY 9, 2024

Adding these developments with the addition of connected IoT devices, supply chain restructuring and consideration for our code of ethics will give us a glimpse at how pharmaceutical production will look in future. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Pharmaceutical Technology

JANUARY 20, 2023

Other factors such as food insecurity and the energy crisis can make existing medical conditions worse, along with the effects of poor air quality and molds on respiratory health. Furthermore, having local knowledge at terminals regarding available freight space ensures efficiency and allows aircraft to carry as many products as possible.

Pharma 142

Pharma Manufacturing Pharmaceutical Distribution 142

pharmaphorum

OCTOBER 27, 2022

Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.

Media 98

Media Pharmaceutical Medicine Electronics 98

Clarivate

MARCH 14, 2024

Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

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 Pharmaceutical products 40

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. Free Webinar.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

European Pharmaceutical Review

APRIL 21, 2023

Hence, every country that looks at decarbonising its health sector – and all EU Member States must – will quickly look at the pharmaceutical industry. 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.

Pharma 98

Pharma Food and Drug Administration Medicine Pharmaceutical 98

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.

Marketing 40

Marketing Healthcare Healthcare Pharma 40

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

Food and Drug Administration 95

Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. JSB : When working with regulatory bodies in the life science industry, data integrity is of utmost importance.

Government 98

Government Pharma Training Ethics 98

European Pharmaceutical Review

DECEMBER 27, 2023

Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. Approved cellular and gene therapy products [Internet]. US Food and Drug Administration. 2021;3(S1):6–10. Center for Biologics Evaluation and Research.

Manufacturing 104

Manufacturing Food and Drug Administration Patients Pharma 104

Pharma Marketing Network

OCTOBER 3, 2024

Understanding Pharmaceutical Marketing Dynamics Pharmaceutical marketing dynamics are shaped by a myriad of factors, including the rapidly evolving healthcare landscape, technological advancements, and shifting consumer expectations. It should be clear, concise, and aligned with the brand’s overall mission and values.

Pharmaceutical 52

Pharmaceutical Marketing Healthcare Healthcare 52

Pharma Marketing Network

OCTOBER 1, 2024

By understanding these strategies, stakeholders in the pharmaceutical industry can better navigate the complexities of promoting their products effectively. Evolution of Marketing in the Pharmaceutical Industry The marketing of pharmaceutical products has undergone significant changes over the decades.

Marketing 52

Marketing Pharma Media Education 52

Pharmaceutical Technology

DECEMBER 13, 2022

Freeze drying, also known as lyophilisation, is a common method of preservation used in many products, from the fresh herbs and vegetables that top store-bought pizzas to the instant coffee in our morning brew. Many pharmaceutical products are sensitive to heat, therefore the ability to dry contents at low temperatures is a clear advantage.

Pharmaceutical 52

Pharmaceutical Manufacturing Pharmaceutical products Food 52

Pharmaceutical Technology

MARCH 6, 2023

Freeze drying has found many applications in the production of sensitive and high-value food, drink and pharmaceutical products. The CLR is a great option for pharmaceutical companies performing steam sterilisation in the drying chamber. But that isn’t the only demanding application in the freeze drying world.

Specialization 52

Specialization Pharmaceutical Food Leads 52

Evolve Your Success

OCTOBER 10, 2023

We can provide services that can help these moms to help reduce their nausea and intake more nutrition and food during their pregnancy. Everyone sits as a family and we all put our food into the broth, take it out, and eat it with noodles. Hot pot is delicious and yummy where you have pots of broth, different flavors of broth.

Medical sales 130

Medical sales Sales Medical Patients 130

European Pharmaceutical Review

APRIL 8, 2025

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q13 Continuous Manufacturing of Drug Substances and Drug Products. Food and Drug Administration (FDA), 2004. International Council for Harmonisation (ICH), 2022. International Council for Harmonisation (ICH), 2022.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

Pharmaceutical Technology

APRIL 26, 2023

The choice of the primary packaging material for pharmaceuticals is influenced by factors such as the product’s physicochemical properties, stability, route of administration, and regulatory requirements.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52

European Pharmaceutical Review

AUGUST 23, 2022

1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. 2 The global counterfeit pharmaceuticals trade is estimated to be worth billions annually, 3 bolstered significantly by the increased illicit online pharmacies that emerged during the COVID-19 pandemic. This allows for a cyber?physical All protein?based

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

Pharmaceutical Technology

JULY 7, 2025

Alembic Pharmaceuticals has acquired UTILITY therapeutics, expanding its portfolio with the addition of Pivya (pivmecillinam 185 mg tablets), a penicillin class antibacterial for treating uncomplicated urinary tract infections (uUTIs). In April 2024, Pivya received approval from the US Food and Drug Administration (FDA) for uUTIs.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Media Biopharma 52

Pharmaceutical Technology

JULY 11, 2025

In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024.

FDA 52

FDA Food and Drug Administration Media Manufacturing 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. 26 April, 2016.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmacology 96

European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Manufacturing Pharmaceutical products 98

European Pharmaceutical Review

DECEMBER 19, 2023

I Woodhead Publishing Series in Food Science, Technology and Nutrition, Maillard Reactions in Chemistry, Food and Health. I Woodhead Publishing Series in Food Science, Technology and Nutrition, Maillard Reactions in Chemistry, Food and Health. 2005;8(3): 559-574. Wolfenden R, Yuan Y. 2008;130 (24):7548–7549. Pages 20-27.

Distribution 111

Distribution Manufacturing Food Specialization 111

Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Pharmaceutical manufacturing Manufacturing 52

Pharmaceutical Representative Training

JUNE 22, 2024

Many different abilities and expertises are needed within pharmaceutical sales including: Scientific Knowledge: Pharma reps need to be well-versed in scientific and medical elements of the different products they sell/market. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

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. How can these issues be addressed?

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Transportation Manufacturing 98