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The guidance reflects FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers,” the agency said. 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CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.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CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.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
Gottlieb and Woodcock spoke out against the media’s questioning of generic drug quality, saying they believe that the data analysis-based reports are faulty. 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CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.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
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