European Pharmaceutical Review

OCTOBER 21, 2022

NCIMB Ltd provides microbial identification services and curates The National Collection of Industrial, Food and Marine Bacteria – one of the culture collections that makes up the UK Biological Resource Centre Network.

Pharmaceutical manufacturing 75

Pharmaceutical manufacturing Food Networking Manufacturing 75

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

FDA 89

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 89

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 76

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 76

World of DTC Marketing

APRIL 12, 2021

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. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). In other words, money over safety.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

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

European Pharmaceutical Review

OCTOBER 23, 2023

1 In pharmaceutical manufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. Pharmaceutical Technology. Stickiness in Foods: A Review of Mechanisms and Test Methods.

Distribution 91

Distribution Food Management Manufacturing 91

PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. Certain markets (e.g.,

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022.

FDA 84

FDA Food and Drug Administration Media Manufacturing 84

European Pharmaceutical Review

NOVEMBER 8, 2022

In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. Her current research is focused on spectroscopy and mathematical modelling as process analytical technologies in pharmaceutical manufacturing. US Food and Drug Administration. US Food and Drug Administration.

Food and Drug Administration 88

Food and Drug Administration Pharma Manufacturing Food 88

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. To advance equity in clinical research, the U.S.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Pharmaceutical Technology

JUNE 23, 2022

National Resilience (San Diego, California) announced on 6 June that it had raised $625m in series D financing, which will be spent in part on continuous manufacturing for biologics. The US House of Representatives separately passed a bill on continuous manufacturing on 19 October last year.

Government 64

Government Manufacturing Food and Drug Administration FDA 64

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 85

Media Pharmaceutical Medicine Electronics 85

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.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

European Pharmaceutical Review

AUGUST 17, 2022

Antibiotics getting into the food chain also plays a key role in the development of AMR. based Targets for Antibiotics in Receiving Waters from Pharmaceutical Manufacturing Operations. Editorial: Horizontal Gene Transfer Mediated Bacterial Antibiotic Resistance. Frontiers in Microbiology. Tell J, Caldwell D, Häner A, et al.

Manufacturing 86

Manufacturing Food and Drug Administration Management Pharmaceutical manufacturing 86

European Pharmaceutical Review

DECEMBER 18, 2023

Pharmaceutical manufacturing Oligonucleotides Last month, the Centre for Process Innovation (CPI) announced a new Scotland-based manufacturing facility focusing on oligonucleotide therapeutics. ZUMA-7 is the first and largest Phase III study of any CAR T-cell therapy, with the longest follow-up.

Manufacturing 96

Manufacturing Food and Drug Administration Medicine Pharmaceutical manufacturing 96

Pharmaceutical Technology

APRIL 18, 2023

The new facilities will also support the company’s efforts to manufacture new therapeutic modalities, including genetic medicines. The company has launched 19 new medicines since 2014, including Jaypirca, which was approved by the US Food and Drug Administration in January 2023 to treat mantle cell lymphoma.

Manufacturing 52

Manufacturing Food and Drug Administration Pharmaceutical manufacturing Medicine 52

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

FDA 89

FDA Food and Drug Administration Manufacturing Product sample 89

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 83

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 83

European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

Manufacturing 74

Manufacturing Pharmaceutical Healthcare Healthcare 74

Pharma Marketing Network

JUNE 11, 2020

If you’re a pharmaceutical company or if you’re an agency or even a consultant.

Pharma 52

Pharma Marketing Media Healthcare 52

Pharmaceutical Technology

MARCH 22, 2023

In December 2022, the US passed its ‘ominous spending bill’ directing the US Food and Drug Administration (US FDA) to establish an advanced manufacturing Centre for excellence and an advanced manufacturing technologies designation programme. What can the EU learn from other countries’ reshoring strategies?

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Food and Drug Administration Manufacturing Government Pharmaceutical 105