Remove Adverse Reactions Remove Communication Remove Definition
article thumbnail

Supporting gut microbiome equilibrium via faecal microbiota transplantation

Hospital Pharmacy Europe

Although there is no universally accepted definition of FMT, it generally refers to the transfer of biological material containing faecal microorganisms from screened, healthy human donors to the GI tracts of patients. The most common adverse reactions are abdominal distension, fatigue, constipation, chills and diarrhoea.

article thumbnail

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

As another example, both documents note the possibility that if FDA has safety information relevant to an ongoing study, it may request that the sponsor confirm that the DMC is aware of that safety data and is taking it into consideration, or “request that the sponsor arrange for FDA to communicate with, or even meet with, the DMC.”

article thumbnail

Antidepressants and Suicide: Why Don’t People Think There’s a Link?

The People's Pharmacy

Antidepressants are, by definition, supposed to improve mood. The drug was eventually outlawed, but only after thousands of adverse reactions and over a hundred deaths worldwide. Families and caregivers should be advised of the need for close observation and communication with the prescriber.”

FDA 81