Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly. She joined NSF in 2017.

Pharmaceutical Manufacturing 119

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies 119

Pharmaceutical Technology

OCTOBER 5, 2022

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. 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.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59