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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
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes. Read More
Inspections of U.S. pharmaceutical manufacturing facilities have seen a declining number of official warnings over the past five years, but the trend is less clear on the international front. Read More
The FDA plans to more than triple its staff in China from eight direct hires to 26, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. 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
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More