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Results: 1-8 of 8

Senators seek clarity on mobile medical apps
  • Shook Hardy & Bacon LLP
  • USA
  • April 3 2014

Seeking clarification on the U.S. Food and Drug Administration's (FDA's) final guidance pertaining to Mobile Medical Applications (apps), a


FDA issues report to Congress on drug shortage mitigation, GAO weighs in
  • Shook Hardy & Bacon LLP
  • USA
  • February 13 2014

In its first annual report to Congress on drug shortages for calendar year 2013, the U.S. Food and Drug Administration (FDA) has provided data


Congress takes FDA to task for inaction over fungal meningitis outbreak
  • Shook Hardy & Bacon LLP
  • USA
  • April 18 2013

A House Energy and Commerce Subcommittee questioned Food and Drug Administration (FDA) Commissioner Margaret Hamburg on April 16, 2013, about the


Congress continues to address reauthorization of FDA user fee law
  • Shook Hardy & Bacon LLP
  • USA
  • January 19 2012

With a number of hearings scheduled before House committees in February 2012, Congress is apparently on track to complete work on measures that would reauthorize the Food and Drug Administration (FDA) to collect user fees before the current law expires on September 30


Venture capital goes to Capitol Hill to decrease regulatory burdens on medical device industry
  • Shook Hardy & Bacon LLP
  • USA
  • November 3 2011

According to a recent New York Times business article, venture capital funds are contributing to the campaigns of politicians calling for streamlined Food and Drug Administration (FDA) medical device approval procedures and increasing their lobbying presence in Washington, D.C


IOM deems 510(k) medical-device clearance process flawed; FDA seeks comments
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

The Institute of Medicine (IOM) has issued a report titled “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years,” calling for an overhaul of Food and Drug Administration (FDA) procedures for approving medical devices that are considered a moderate risk to patients and are substantially equivalent to any previously cleared device or one that was on the market before the Medical Device Amendments were enacted in 1976



Chris A. Johnson
  • Shook Hardy & Bacon LLP