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The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
In a win for drugmakers, President Barack Obama signed into law a bill that extends exclusivity periods for new drugs and biologics containing a controlled substance by changing the date they are considered to have been approved from the current FDA sign-off to when the Drug Enforcement Agency schedules them for sale. Read More
Fabre-Kramer Pharmaceutical’s depression candidate gepirone could be held back yet again in its fourth go-around, with the FDA questioning whether two successful trials are enough to prove its value alongside a “relatively large” number of negative trials. Read More
Observations cited in a Form 483 need to be reviewed carefully, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More