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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds

European Pharmaceutical Review

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending. billion (3.3

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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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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

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Establishing quality assurance in personalised preparations

European Pharmaceutical Review

Quality assurance for personalised preparations According to the authors, the personalised preparation quality assurance program (PACMI) was created in 2010 at the Faculty of Health Sciences of San Jorge University in Spain. These are documented and their root cause is sought. PACMI selects a drug on a quarterly basis.

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510(k) Modernization 2023

The FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Fifth scientist convicted in GSK trade secrets case

pharmaphorum

Gongda Xue (52), a Chinese citizen formerly working at the Friedrich Miescher Institute for Biomedical Research in Switzerland, has been found guilty of conspiracy to steal trade secrets in relation to medicines under development at GSK between January 2010 and January 2016. She was sentenced to eight months in prison in May 2021.

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New RSV therapies may accelerate the emergence of resistant strains

Pharmaceutical Technology

Cases of palivizumab-resistant RSV strains have been documented as early as 2010, roughly 12 years after the mAb entered the market. In 2010, a palivizumab-resistant RSV strain was isolated from a preterm infant at 25 weeks of gestation, who was treated with three doses of palivizumab over a period of approximately 140 days.