New FDA Program for Mail Back Envelopes for Opioids – Good News or Bad News?

On Monday, the FDA announced a change to the REMS for opioids to include a requirement “to make prepaid mail‑back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”  As part of the new, revised REMS requirement, “all manufacturers of opioid analgesics used in outpatient settings are […]

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Milligram Equivalents of Morphine – What is This About?

For those of you that are not directly in the pharmaceutical industry or who are not healthcare providers, you may wonder why the FDA is having a meeting to discuss the morphine milligram equivalents for other opioids.  Well, I know that measure gives healthcare providers a good idea of how to transition patients taking morphine […]

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Opioids Front and Center as FDA Issues Notice of Public Hearing and New Draft Guidance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