Celator Pharmaceuticals received fast-track designation for its candidate for the treatment of secondary acute myeloid leukemia in elderly patients. CPX-351 is designed to achieve sustained release of the anticancer drugs cytarabine and daunorubicin in a precise ratio.
The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.
An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.
Dozens of angry patients who claim they were injured by LASIK eye surgeries are banding together in an attempt to pressure the FDA to crack down on providers of the therapy.
The Medical Testing Availability Act of 2015 would restrict the ability of the FDA to enforce tacit marketing of "research use only" diagnostics for clinical purposes. The bill is sponsored by Rep. Michael Burgess (R-TX), who is also spearheading opposition on Capitol Hill to FDA's plans to regulate laboratory-developed tests.
The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.
The FDA has shared details of plans for its Office of Pharmaceutical Quality. Staffers plan to group drug production operations by category and release an average quality grade for each bucket, allowing manufacturers to see if they are outperforming their peers.
The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.
The Indian state of Gujarat has hit upon a way to bring its inspectors up to international standards: Hire the company that provides online training to the FDA. Officials at the Gujarat Food and Drug Control Authority will have access to training services from UL EduNeering, the company that has helped the FDA develop its educational program since 1999.
"Modified release is a high-risk area, so we're going to put a lot of emphasis on it," said the deputy director of the FDA's new Office of Pharmaceutical Quality, Lawrence Yu, during a press conference describing the new division.