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The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More
The FDA is expected to start training investigators next year on how to tell whether a facility’s quality culture is good or poor, a development that lays the groundwork for eventual scrutiny of this new indicator during inspections. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More