A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More

A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More

CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action. Read More

CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action. Read More

A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force. Read More

A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force released on Tuesday. Read More

CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Read More

FDA Commissioner Scott Gottlieb and CDER director Janet Woodcock rallied Friday against recent media claims that generics are of lesser quality than brand name drugs, outlining methods the agency takes to protect their quality and effectiveness. Read More

CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Read More