FDA makes big progress on GDUFA backlog
SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research has achieved its goal of clearing some of the backlog under the Generic Drug User Fee Agreement, according to an email sent by CDER director Janet Woodcock.
The agency has acted on more than 90% of backlogged applications for generics and prior approval supplements that were pewith FDA or industry as of Oct. 1, 2012. This puts the agency more than a year ahead of schedule, under the five-year funding period authorized by GDUFA, the FDA is required to clear the backlog by Sept. 30, 2017.
“Most applications from the backlog will need to come back to FDA for additional review before approval is possible, so we still have a lot of work ahead of us,” Woodcock’s email said. “But this is a significant milestone. We are exceeding our negotiated GDUFA commitments.”
Survey: Pharmacists lead pack when it comes to patient trust
WEST DES MOINE, Iowa — A new survey conducted by Meyocks has found that pharmacists are the most trusted group in the healthcare industry. According to the Meyocks Health Survey, 60% of patients trust pharmacists, 26% have a neutral opinion and 14% don’t trust them — both the highest trust rate and the lowest distrust rate among other groups in the survey.
Doctors and dentists trailed pharmacists, with 56% and 51% of people saying they trusted them, respectively. Ranking lower were executives at insurance companies, who 55% of respondents said they distrust. Members of Congress fared worst in the survey, with only 9% of survey respondents saying they trusted them, with 72% expressing distrust.
“In general, Americans trust the people who directly provide health care more than others in the system,” Meyocks president Doug Jeske said. “Still, these results should be another wake-up call to those in the health care industry. We live in a polarized, skeptical society, and the health industry isn’t immune to that. Americans are looking for transparency and positive actions in a time of economic and cultural uncertainty, and key members of the health care system are struggling to deliver – or to get credit for the good things they are doing.”
FDA approves Shire’s Xiidra
SILVER SPRING, Md. — The Food and Drug Administration has approved Shire’s Xiidra (lifitegrast ophthalmic solution, 5%), the company announced Tuesday. Xiidra is twice-daily eyedrop solution indicated to treat signs and symptoms of dry eye, which affects an estimated 16 million adults in the U.S. The drug is the first approval from Shire’s ophthalmics pipeline
“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition,” Shire CEO Dr. Flemming Ornskov said. "As Shire's first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs.”
Shire said it expects Xiidra to be available in the third quarter of 2016.
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