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About Nielsen

+25 year(s) experience

Nielsen has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining Pink Sheet, he worked for Congressional Quarterly.
As Executive Editor, US Regulatory and Policy, Nielsen leads Pink Sheet’s US coverage and collaborates across Informa Pharma Intelligence’s publications. He supports the insightful news and deep analysis on how to get your product developed, approved, and reimbursed, and oversees Pink Sheet’s team of reporters who are experts on everything from ANDAs to Zika vaccines, offering lively stories that help subscribers understand the personalities, policies, and pain points that dictate whether their regulatory strategy succeeds or fails. Features such as the FDA Performance Tracker and Drug Review Profiles illuminate the inner workings of the agency.

Nielsen is a frequent speaker and moderator at industry conferences, and enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).

Specialties

  • Policy & Regulation
  • Generics

Nielsen Writes For

Analyst Articles

Articles by Nielsen

  • Pink Sheet

    Webinar: FDA and its Commissioners

    By Nielsen Hobbs 05 Nov 2019

    Webinar

    The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

    Topic FDA

    Full video

  • Pink Sheet

    US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

    By Nielsen Hobbs 30 Aug 2018

    US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

    "At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."

    Topic FDA

    View article