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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Drug pricing increases are disgraceful

World of DTC Marketing

Among the 25 worldwide companies that spend the most on research and development—all more than $5 billion a year—seven are pharmaceutical manufacturers, but eight are automobile or automobile-parts companies with profit margins under 10 percent. years to win FDA approval, at a median cost of $648 million.

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Non-stop investment from CMOs and US Government into continuous manufacturing

Pharmaceutical Technology

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.

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Precision Medicine Needs an Overhaul

PM360

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. The EMA and the FDA also joined hands to advance precision medicine for rare disease patients.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

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. Eight FDA warning letters were handed to European companies in 2018.

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Ep. 002 – John Mack Podcast Transcript

Pharma Marketing Network

And do that, you interviewed me back in 2015, for the results book. I mean, every aspect of the industry from FDA approvals and regulations to the actual nuts and bolts of marketing and what works and what doesn’t work. If you’re a pharmaceutical company or if you’re an agency or even a consultant.

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