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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 As of October 2023, 62.93

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2021 market access prospects for Germany

pharmaphorum

IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. Any changes to AMNOG will likely be a worry to industry as there has already been a toughening in AMNOG assessments since 2011.”. Figure 1: AMNOG procedures and findings, 2011-2019. Tougher pricing?

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Further, Trustedoctor merge to provide ‘borderless’ healthcare

pharmaphorum

First launched in 2016, Trustedoctor was born from the experiences of founder and CEO Greg Jarzabek whilst trying to get the best care for his mother, who died of pancreatic cancer in 2011.

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Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

FDA Law Blog: Biosimilars

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.

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Antimicrobial Choice

RX Note

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g. before the availability of culture or susceptibility testing result).

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Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

At the moment, it started off with, you know, five 8 10 million in 2011. And the number of deals that are going up, sort of number of deals that are being done are also going up from a high of 300 in 2011, to about 800 deals in 2018. And it’s gone up to about 30 million. So we’ve seen the deals are becoming larger.

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Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

At the moment, it started off with, you know, five 8 10 million in 2011. And the number of deals that are going up, sort of number of deals that are being done are also going up from a high of 300 in 2011, to about 800 deals in 2018. And it’s gone up to about 30 million. So we’ve seen the deals are becoming larger.