February Drug Recalls
This article was originally published in The Gold Sheet
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Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers
FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.
Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers
FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.
FDA Warning Letters Hit Inadequate Investigations and QC Failings
In recent warning letters, FDA continued to hammer manufacturers for inadequate investigation of out-of-specification results and lax oversight of manufacturing operations by quality control units.