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PDA revises report on glass container manufacturing

European Pharmaceutical Review

Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types. According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

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NHS data sharing scheme “on hold” as millions opt out

pharmaphorum

The possibility of data being shared with third-parties including academic researchers and pharmaceutical companies raised concerns about whether the public is aware that they stand to lose control of private information on their physical, mental and sexual health. Now that’s been set back indefinitely. survey conducted in July.

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia. 2013 Oct; 48(10): 943–953. Published online 2013 Jul 2. Mayer-Hamblett N, Rosenfeld M, Treggiari MM et al. Pediatr Pulmonol. doi: 1002/ppul.22693. Thompson, LA.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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How will NICE fare in a post-Brexit world?

pharmaphorum

Practically though, there are risks of additional processes and requirements (and expense) for pharmaceutical companies. It is also possible that companies may prefer to enter the EU market through the EMA process and avoid additional processes involving the MHRA and NICE.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Ferry describes a popular solution among pharmaceutical companies. The $900 million dollar settlement was previously announced in June but has only been finalized this month.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. But a whistleblower at the company reported that some of the scientists there were falsifying data. Carcinogens in Blood Pressure Meds?

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