Newsletter - June 2, 2022
FDA and EMA Inspectors Found Similar Issues at GCP Inspections
A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both...Read More
The Speed of Covid Vaccine Development is an Exception, Not the New Norm
The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be...Read More
FDA and EMA Inspectors Found Similar Issues at GCP Inspections
A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both...Read More
The Speed of Covid Vaccine Development is an Exception, Not the New Norm
The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be...Read More
