The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs
further underscored the program's shortcomings. FDA has been trying to get the drug, Makena, off the market for more than two years, because a follow-up study showed it didn't benefit infants or mothers. The manufacturer has refused to cooperate.
An FDA spokeswoman said the agency's posture on accelerated approval “has remained consistent and the agency is committed to ensuring the integrity of the program.” She added that FDA is using “every authority at our disposal” to make sure drugmakers quickly conduct confirmatory studies after approval.
The picture is beginning to change. In less than two years, the FDA has successfully called on drugmakers to remove more than 20 approvals from accelerated drugs — mainly— that failed to show a benefit. That's more than half the withdrawals in the program's history. “We need more teeth in terms of getting the confirmatory trials started before accelerated approval,” FDA Commissioner Robert Califf said at a recent cancer conference. “Once approval occurs it’s very difficult to hold back the marketeers.”
A higher bar could spell trouble for smaller drugmakers, who often rely on accelerated approval to gain a market foothold before raising additional funds. Additionally, COVID-19 pandemic disruptions forced some drugmakers to cut short their research plans, asking FDA for accelerated approval based on partially completed studies, instead of a full results.
Norge Siste Nytt, Norge Overskrifter
Similar News:Du kan også lese nyheter som ligner på denne som vi har samlet inn fra andre nyhetskilder.
Sesame to become 9th ‘major food allergen’ on Jan. 1, FDA saysEight foods were previously identified as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans. The FASTER Act will add sesame to the list of major food allergens effective Jan. 1, 2023.
Les mer »
Panel calls for stronger leadership of FDA food programsFDA Commissioner Dr. Robert Califf said he would consider which changes to make after reviewing the report and consulting with experts inside and outside the agency.
Les mer »
FDA announces recall of frozen raspberries due to possible hepatitis A contaminationMore than 1,000 cases of James Farm frozen raspberries are being recalled. The Food and Drug Administration (FDA) says the product may be contaminated with hepatitis A.
Les mer »
Pfizer asks FDA to clear updated COVID shot for kids under 5Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5 — not as a booster but part of their initial shots.
Les mer »
Pfizer asks FDA to clear updated COVID shot for kids under 5Pfizer and its partner BioNTech said Monday that may help prevent severe illness and hospitalization from COVID-19 in little kids, at a time when children’s hospitals already are packed with youngsters hit by other respiratory illnesses.
Les mer »