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    • Strategic Drug Development
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      • Pre-IND Meetings
      • Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
      • Clinical Trial Design
      • Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
      • 505(b)(2) NDAs
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      • Exempt Devices / 513(g) Submissions
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Daily Archives: August 19, 2016

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Types of FDA Drug Labeling

Types of FDA Drug Labeling and Their Requirements

Labeling / MarketingBy PDG Regulatory ExpertAugust 19, 2016

Introduction FDA is charged with the duty of regulating the manufacture, sale and distribution of both prescription drugs and nonprescription drugs (aka over-the-counter or OTC medications).[1] A significant FDA role in the regulation of these medications is supporting sponsors in their efforts to ensure adequate drug product labeling. In this paper, we will describe the…

FDA Takes Unprecedented Step Toward Encouraging Rx-to-OTC Switch

Breaking NewsBy PDG Regulatory ExpertAugust 19, 2016

FDA recently announced on FDAVoice that they plan to facilitate ways to encourage industry to submit an NDA for an Rx-to-OTC switch. The announcement directly addresses prescription naloxone, indicated for treatment of opioid overdose. This unusual step is consistent with FDA’s opioid action plan and is aimed at making the drug more widely available. To…

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