FDA plans to revamp cGMP rules

The plans of FDA to reassess the cGMP rules for drug manufacturing are discussed. The planned changes include a shift to focus on products with the greatest risk, and on making it easier for products to use new production technology. The goal of the program will be 'to enhance the focus of the agency's cGMP requirements more squarely on potential risks to public health, by providing additional regulatory attention and agency resources on those aspects of manufacturing that pose the greatest potential risk. The decision of the FDA will ensure that patients continue to benefit from timely access to high-quality pharmaceutical products manufactured.