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Faced with a huge backlog of generic drug applications, the FDA’s Office of Generic Drugs (OGD) announced it is now using an electronic filing system — in use by another division of the FDA since 2000 — that the OGD said will make it more efficient at reviewing applications.
An FDA advisory committee is recommending that the agency require drug manufacturers to submit new drug applications (NDAs) for products containing nanotechnology, adding an influential voice to the growing debate over the FDA’s regulatory strategy for these products.
The growing number of nanotechnology-based device and drug applications submitted to the FDA is putting further strain on the already overloaded agency, according to one witness at a public meeting the agency held on nanotechnology.
Faced with a huge backlog of generic drug applications, the FDA’s Office of Generic Drugs (OGD) announced it is now using an electronic filing system — in use by another division of the FDA since 2000 — that the OGD said will make it more efficient at reviewing applications.
The growing number of nanotechnology-based device and drug applications submitted to the FDA is putting further strain on the already overloaded agency, according to one witness at a public meeting the agency held on nanotechnology.
A nanotechnology industry group is taking issue with a report commissioned by the Project on Emerging Nanotechnologies that asserts that the agency lacks both the legal and financial resources to regulate products containing nanomaterials, saying the agency in fact has “robust legal authority” to carry out the job.
The FDA’s plan to fight counterfeiting by tracking drugs through a pedigree system is not likely to accomplish the agency’s goals because of flaws in the federal statute, an expert says.
Sites should look for flexibility when shopping for electronic data capture (EDC) systems and should be aware of the increasing potential for integrating information from electronic medical records (EMRs), according to one prominent vendor.