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How ICH E6 (R3) is changing clinical trials

Pharmaceutical Technology

Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance. To explore how Zelta can support your organization’s clinical data management needs, download the document below.

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Uncertainty looms over FDA scheme to boost US manufacturing

Pharmaceutical Technology

Find out more The first stage, called the Facility Readiness phase, will allow more frequent communication with the FDA to discuss facility design, construction, and pre-production. The FDA says this should be done via Type V Drug Master File (DMF), a document that can be incorporated into drug applications to support approval.

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George Tidmarsh to sub in as FDA CBER head following Prasad’s shock exit

Pharmaceutical Technology

The document also confirms that deputy directors Scott Steele and Brittany Goldberg will continue to serve in their respective positions within the CBER executive committee. Give your business an edge with our leading industry insights. Thank you for subscribing View all newsletters from across the GlobalData Media network.

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Sign up for our daily news round-up!

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GSK’s Blenrep US comeback hindered by eye safety concerns

Pharmaceutical Technology

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.

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Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

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Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. Give your business an edge with our leading industry insights. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.