Policy: Regulatory

Subtopics:

REGULATORY:

Public or Private?

Commercial confidential information need to be protected to ensure innovation.


A spate of recent non-approvable letters from the U. S. Food and Drug Administration to drug companies has helped fuel, particularly on Wall Street and amongst the media, a discussion on FDA transparency and corporate honesty. Such “classified” information leaves the public in the dark about what stood behind agency decisions and leaves it in the hands of the companies to make whatever information they care to make public.

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  • Conversations From BIO 2008
    Podcast: July 2008
    June 26, 2008 - Policy - Regulatory
  • A Balancing Act
    We need FDA reform that makes drugs safer, but does not slow down the flow of new medicines, or discourage the creation of them altogether.
    May 21, 2008 - PETER J. PITTS - Policy - Regulatory
  • Let Them Have Their Say
    Patients should have access to information from every source including drugmakers.
    April 23, 2008 - PETER J. PITTS - Policy - Regulatory
  • Naughty or NICE?    
    The U.K.'s National Institute for Health and Clinical Excellence could be a model for the U.S. healthcare system, but critics say the agency stifles innovation and limits access.
    February 04, 2008 - HELEN JOYCE - Policy - Regulatory
  • PODCAST: February 2008
    February 01, 2008 - Policy - Regulatory
  • Fools on the Hill
    Politics triumphs over public health as a spending package blocks funding for newly-created foundation to advance drug development.
    December 26, 2007 - PETER J. PITTS and ROBERT GOLDBERG - Policy - Regulatory
  • Inspecting the Inspectors
    GAO finds weaknesses in FDA's program for inspecting foreign drug manufacturers.
    November 28, 2007 - Policy - Regulatory
  • Critical Wrath
    The FDA should not be chastised, but applauded for working with industry to tackle the big problems of drug development.
    October 16, 2007 - PETER PITTS - Policy - Regulatory
  • Pushing Drugs    
    Big pharma would love to see more countries allow direct advertising.
    October 01, 2007 - BETTE FLAGLER - Policy - Regulatory
  • Bad Medicine
    To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.
    September 25, 2007 - PETER PITTS - Policy - Regulatory
  • Genetic Discrimination
    American's don't want to share information about their DNA with just anyone.
    September 10, 2007 - Policy - Regulatory
  • Why the Controversy Misses the Point    
    A focus on embryos and cures has obscured an invaluable research tool.
    September 01, 2007 - By Gareth Cook - Policy - Regulatory
  • Amgen Feeling Anemic
    Reimbursement restrictions could trigger a wallop from private payers.
    August 06, 2007 - DANIEL S. LEVINE - Policy - Regulatory
  • Phoning It In
    The FDA needs to rethink the way it communicates in an age of empowered patients.
    August 01, 2007 - PETER PITTS - Policy - Regulatory
  • FDA Thinks Small
    Agency task force wrestles with the regulatory challenges posed by nanotechnology, but critics say its business as usual.
    July 27, 2007 - DANIEL S. LEVINE - Policy - Regulatory
  • Revamping the FDA
    Agency needs to adopt new tools to do its job in the 21st century.
    July 13, 2007 - PETER PITTS - Policy - Regulatory
  • Worried Sick
    Biotech execs see regulatory burdens as the industry's biggest challenge.
    May 14, 2007 - Policy - Regulatory
  • Is It Safe?
    Drug-approval delays threaten public safety.
    May 08, 2007 - PETER PITTS - Policy - Regulatory
  • Mixing Molecular Metaphors
    Andrew von Eschenbach says the FDA needs to change.
    May 07, 2007 - DANIEL S. LEVINE - Policy - Regulatory
  • Eye on the Street
    The latest news and numbers from Wall Street.
    January 22, 2008 - Business - Markets
  • Eye on the Street
    The latest news and numbers from Wall Street.
    January 22, 2008 - Business - Markets
  • PODCAST: January 2008
    December 31, 2007 - Business - Global Economy
  • Uncovering the Potential    
    September 01, 2007 - By David Gollaher - Policy - Regenerative Medicine
  • A Digital Liver
    Federal regulators hope computer modeling can identify drugs that damage the liver before they do harm.
    August 13, 2007 - DANIEL S. LEVINE - Science - Technology