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Products & Services Quality, Compliance and Regulatory Regulatory Affairs

The Role of Regulatory Affairs in Preparing for NDA Interactions

ID: 5030


Features:

2 Info Graphics

6 Data Graphics

50 Metrics

10 Best Practices


Pages/Slides: 19


Published: Pre-2013


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "The Role of Regulatory Affairs in Preparing for NDA Interactions"

STUDY OVERVIEW

Positive working relationships with FDA officials can help an NDA progress efficiently through the regulatory process. Lack of good communication can drag out a submission or, potentially, doom it. Regulatory Affairs leaders face a plethora of responsibilities but one of the most important is helping prepare a company’s team for NDA-related meetings.
This study examines the role of Regulatory Affairs groups in helping the NDA navigate FDA’s process and preparing development teams for interactions with regulators and advisory committees.
Regulatory leaders can use the insights from this research to compare and adjust their group’s approach to interactions with the FDA.

KEY TOPICS

  • Executive Summary
  • Starting with the NDA
  • Who Speaks, Leads
  • Working with the Project Manager
  • Preparing for NDA Meetings
  • Meeting Rehearsals
  • Negotiating for a Win-Win with Labeling


KEY METRICS
  • Top Methods for Working with the FDA
  • Effectiveness Rating of Interaction Approaches
  • Groups and Roles during the NDA Process
  • Use of Expert/Outside Consultant
  • Effectiveness Rating of Preparation Approaches for Advisory Committee Meetings
  • Ranking of Top Three Preparation Approaches for Advisory Committee Meetings

SAMPLE KEY FINDINGS
  • Develop flexible negotiation skills that identify key points to defend and preserve in the NDA – and create flexible options for compromise on nonessential issues or on non-negotiable issues such as public safety. Look for win-win solutions.
  • Draft label submission can represent opportunity or risk so organizations need to balance aspiration and realism. Early interactions with the FDA can help accelerate or slow your NDA process.


METHODOLOGY

The research employed a data gathering approach that gleaned quantitative data from 15 biopharma companies and one medical device company through a detailed survey. In addition, 13 Regulatory leaders participated in in-depth interviews.

Industries Profiled:
Medical Device; Biotech; Chemical; Pharmaceutical; Manufacturing; Consumer Products; Diagnostic; Health Care


Companies Profiled:
Medtronic; Genentech; Alcon; Bayer; Lilly; Amgen; Roche; Novartis; Valeant; United Therapeutics; Bristol-Myers Squibb; Solvay Pharmaceuticals; AstraZeneca; Boehringer Ingelheim; Merck


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