Opioids

20
Jun
Someone in pain

Opioids Front and Center as FDA Issues Notice of Public Hearing and New Draft Guidance

In two separate Federal Register (FR) notices today, the FDA announced a public hearing (here) to be held on September 17, 2019.  The notice states: This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, […]

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30
May
pills and capsules

FR Notice Shows FDA Eager to Entertain/Require Packaging Options for Opioid Containing Products

In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]

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