Newsletter - May 6, 2021
FDA’s Auditing Resources Are Mostly Spent for Food Facilities, Not Drugs.
If every time you heard about an FDA audit and you guessed it was about audit of drug manufacturing facilities, you guessed wrong. More than 80% of surveillance audits conducted by the FDA are at food facilities, compared to about 4% at drug facilities. There are many such surprising facts in a report on FDA inspections....Read More
How Much to Pay the Patients to Participate in Clinical Trials in the Pandemic
Paying patients to participate in clinical trials is common practice. Generally, these payments to clinical trial participants are justified to compensate for their time, inconvenience, discomfort, or some other considerations. Should a patient be paid higher for the increased perceived risk of visiting a clinic in the pandemic...Read More
FDA’s Auditing Resources Are Mostly Spent for Food Facilities, Not Drugs.
If every time you heard about an FDA audit and you guessed it was about audit of drug manufacturing facilities, you guessed wrong. More than 80% of surveillance audits conducted by the FDA are at food facilities, compared to about 4% at drug facilities. There are many such surprising facts in a report on FDA inspections....Read More
How Much to Pay the Patients to Participate in Clinical Trials in the Pandemic
Paying patients to participate in clinical trials is common practice. Generally, these payments to clinical trial participants are justified to compensate for their time, inconvenience, discomfort, or some other considerations. Should a patient be paid higher for the increased perceived risk of visiting a clinic in the pandemic...Read More
