Abuse-Deterrent Opioids: FDA Advocates Joint Brand-Generic Development Plan
Despite ‘tension’ between two industries over what is required to show generic is no less abuse-deterrent than innovator opioid, FDA’s Throckmorton suggests they come up with single approach to product development.
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ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.
KemPharm Seeks FDA Dispute Resolution Over Apadaz's Abuse Deterrence
Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.
Abuse-Deterrent Opioids Effectiveness, Value To Get ICER Review
Pending arrival of several new products prompts evaluation of class, ICER CSO Dan Ollendorf explains; availability of both abuse-deterrent and non-abuse-deterrent drugs among challenging issues.