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FDA's guidelines for petitions filed under section 505(q) of Food, Drug, and Cosmetic Act
  • Duane Morris LLP
  • USA
  • June 16 2011

The U.S. Food and Drug Administration (FDA) recently published its guidelines related to citizen petitions and petitions for stays of action under section 505(q) of the federal Food, Drug, and Cosmetic Act (a "Petition").


The FDA issues its first two regulations implementing the Food Safety Modernization Act
  • Roetzel & Andress
  • USA
  • May 12 2011

On May 4, 2011, the Food and Drug Administration (FDA) issued the first of its new regulations implementing the Food Safety Modernization Act (FSMA) enacted into law in January.


FDA meeting to discuss FSMA preventive controls for facilities
  • Shook Hardy & Bacon LLP
  • USA
  • April 15 2011

The Food and Drug Administration (FDA) has announced an April 20, 2011, public meeting to discuss a Food Safety Modernization Act (FSMA) mandate to implement "comprehensive, science-based preventive controls across the food supply."


Parallel review between the CMS and the FDA
  • Bradley Arant Boult Cummings LLP
  • USA
  • July 29 2010

With the recent inking of a Memorandum of Understanding ("MOU") between the Centers for Medicare & Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") concerning sharing information and expertise, these two agencies are inching toward parallel reviews for marketing approval and Medicare coverage.


FDA guidance documents
  • Reed Smith LLP
  • USA
  • October 15 2009

The FDA has issued a final guidance document for industry on "Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007."


Areta Kupchyk
  • Reed Smith LLP