European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 105

Ethics Medicine Education Competition 105

PM360

SEPTEMBER 28, 2022

PM360 spoke to Kokino about the evolution of the biosimilars market from its nascent days, why the now increased competition within the market is causing some companies to reconsider developing biosimilars, what to look for over the next few years, and how Accord’s approach is a bit different from what other companies are doing.

Competition 98

Competition Marketing Manufacturing Biopharma 98

Pharmaceutical Technology

FEBRUARY 24, 2023

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

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Pharma Medicine Competition Marketing 64

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).

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Medicine Biopharma Safety Food 52

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.

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Medical Government Marketing Medicine 117

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. In 2021, they accounted for 0.2%

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Pharma Food and Drug Administration Safety Medicine 98