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Opioids Front and Center as FDA Issues Notice of Public Hearing and New Draft Guidance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