CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.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CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.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CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.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CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.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

The FDA released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. Read More

The FDA released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. Read More