2009 Documentation Pharmaceutical Companies 
pharmaphorum
NOVEMBER 17, 2020
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gareth has been with the Clinical Research Network since 2009. Embedding the patient voice not only in research, but everything they do.
European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. They detail the medication’s intended use, proper administration, potential side effects and precautions.
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Pharmaceutical Technology
OCTOBER 5, 2022
Bringing an end to a 13-year deliberation on a whistleblower lawsuit, Biogen recently agreed to pay a $900 million settlement , amidst increased government alertness on pharmaceutical fraud. In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings.
pharmaphorum
DECEMBER 28, 2022
In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness?
Eye on FDA
JANUARY 9, 2022
As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. in November 2009.
Syner-G
AUGUST 21, 2022
In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.
Eye on FDA
JULY 7, 2020
The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications. OPDP has indicated in the past that the use of sponsored links without risk information is a no-no.
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