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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 While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance.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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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023.

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Digital investment promises to accelerate the use of wearable sensor data in clinical trials

pharmaphorum

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense software is developed specifically for analysis of data from wearable sensors”, explains Tabakin. “The This brings us to VivoSense.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

10 Diagnostics and biologics also heavily utilise carbon-based materials as constituting building blocks, processing aids, single-use reactors, or packaging materials. He is currently group leader of the Technology Development and Discovery Group at the Bioprocess Laboratory of the ETH. 349, 15 October 2017, pp.

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Pre-Filled Syringes East Coast 2022

pharmaphorum

Who should Attend: Drug-delivery developers. Primary Packaging material designers. Secondary packagers. Smart device developers. Training device developers. Drug developers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Medical Device Engineers.

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Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

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