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

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

FEBRUARY 2, 2023

This left pharmaceutical companies in Europe with no European API supply source, and only a few suppliers in Asia. The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe.

Generic Medicine 111

Generic Medicine Packaging Documentation Pharmaceutical Companies 111

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 97

Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97