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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

3 GlobalData’s analysis shows that the number of clinical trial investigators globally fell from approximately 128,303 in 2017-18 to 116,948 in 2023-24 – a decline of almost 10%. To learn more about the solutions provided by Paradigm Health, download the document below. How will RFK Jr’s American dream for vaccines play out?

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

In addition, the TCI market is projected for significant growth, rising from $13m in 2017 to $30bn in 2030, says GlobalData. In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. How will RFK Jr’s American dream for vaccines play out?

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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Biosimilars

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A.

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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

These standardised documents provide meticulously curated and scientifically approved information. 2017) “Danmark har flest smartphones i hele verden”, Berlingske, Eurostat (2022) “Medicine Use Statistics” European Commission. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020).

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Safe Handling of Hazardous Drugs

RX Note

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

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Impacts of pharmaceutical pollution on communities and environment in India

Express Pharma

The enduring harmful effects of these substances on human health are well-documented, leading to regulatory controls in numerous countries. The National Action Plan for Antimicrobial Resistance 2017 aims to limit antibiotics in industrial waste. Discharging antibiotics can promote antibiotic-resistant pathogens.