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.”
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharma in Brief
OCTOBER 28, 2021
As we previously reported , the ATI Request concerned Health Canada submission documents for Fortekor, an Elanco Canada Limited ( Elanco ) veterinary drug product. In the judgment, “Records” had been defined to mean the entire third-party request, which included documents that Elanco conceded were not confidential and could be disclosed.
pharmaphorum
SEPTEMBER 13, 2022
The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 2002 – Emergence of CAR-T therapy. At the time, his hypothesis appeared to fall on deaf ears, and it would take a further three decades before Hodgkin’s discovery was recognised.
Putting Patients First Blog
APRIL 25, 2023
Similar patient experiences are supported by the 2003 Institute of Medicine’s (IOM) findings in Unequal Treatment that documented disparities in clinical interventions. Washington (DC): National Academies Press (US); 2002. 2 Unfortunately, health outcome indicators are still demonstrating inequities. DOI: [link].
European Pharmaceutical Review
JULY 20, 2023
SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].
The Thyroid Pharmacist
FEBRUARY 10, 2023
A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. Endocr Rev.
Expert insights. Personalized for you.
98 
Let's personalize your content