Newsletter - October 12 2017
FDA’s “Love”-Less Warning Letter to a Boston Bakery: Food GMP Overkill?
Last month FDA sent a Warning Letter citing GMP and labeling violations to a bakery based in the suburbs of Boston which could be perceived by many to be an example of overkill by the Agency auditors, and is some ways it is. The most outrageous statement in the FDA letter was to ding the company for listing “love” as one the ingredients of its products. Read More
CTTI Suggests Ways to Reduce “One And Done” Clinical Investigators
About half of the physicians who participate in clinical trials do only one trial, never doing another one. About half of the investigators in clinical trials are new, doing their first, and possibly last, clinical trial. Doctors do not do second trials because of the extra work and time needed to conduct a trial and to negotiate the budget. Read More
FDA’s “Love”-Less Warning Letter to a Boston Bakery: Food GMP Overkill?
Last month FDA sent a Warning Letter citing GMP and labeling violations to a bakery based in the suburbs of Boston which could be perceived by many to be an example of overkill by the Agency auditors, and is some ways it is. The most outrageous statement in the FDA letter was to ding the company for listing “love” as one the ingredients of its products. Read More
CTTI Suggests Ways to Reduce “One And Done” Clinical Investigators
About half of the physicians who participate in clinical trials do only one trial, never doing another one. About half of the investigators in clinical trials are new, doing their first, and possibly last, clinical trial. Doctors do not do second trials because of the extra work and time needed to conduct a trial and to negotiate the budget. Read More
