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An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new report.
The FDA is rejecting the notion that it should allow unapproved prescription drugs that meet category-wide safety and efficacy standards to be approved for marketing, arguing that the risks are too great and that the approach is too expensive and time-consuming.
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
Improved drug safety is foremost in the FDA’s Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
The process for IRBs to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
The FDA is rejecting the notion that it should allow unapproved prescription drugs that meet category-wide safety and efficacy standards to be approved for marketing, arguing that the risks are too great and that the approach is too expensive and time-consuming.
The FDA wants industry feedback in response to new recommendations made by World Health Organization (WHO) experts that would ease international restrictions on the handling of dronabinol, the main active principle of cannabis, and its stereoisomers.
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
Rather than giving the FDA new regulatory authority, as has been suggested by some lawmakers and the Institute of Medicine, government decisionmakers need to give the agency more funding, the agency’s outgoing deputy commissioner for medical and scientific affairs told D&DL.