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IVDT Page | Category Index

IVD Technology
Articles by Category - FDA

2007 | 2006 | 2002 | 2001 | 2000 | 1999 | 1996 | 1995

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2007

• (Final Thoughts) Adapting to FDA guidances, James R. Prudent (IVDT, Nov 2007, p. 70).

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2006

• "(Industry News) FDA, diagnostics industry seek to remedy genetic testing snags", Matt Grebow (IVDT, Jun 2006, p. 13).

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2002

• (Industry News) CDRH announces new IVD office, Richard Park (IVDT, Nov 2002, p. 14). Keyword: Industry.
• (Industry News) Opinions differ over anthrax testing guidelines, Richard Park (IVDT, Sep 2002, p. 18). Keyword: Testing.
• (Industry News) CBER releases guidance on nucleic acid plasma-screening tests, Richard Park (IVDT, Mar 2002, p. 14). Keywords: Regulatory Affairs.
• (Industry News) Industry applauds Medicare final rule for lab tests, Richard Park (IVDT, Mar 2002, p. 14). Keywords: Regulatory Affairs.

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2001

• (Industry News) Gene-patenting rules finalized (IVDT, Apr 2001, p. 11). Keyword: Industry.
• (Industry News) Waived-complexity guidance (IVDT, Apr 2001, p. 11). Keyword: Industry.

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2000

• (News) DCLD restructuring, Susan Wallace (IVDT, Nov 2000, p. 16).
• (News) FDA genetic testing panel created, Susan Wallace (IVDT, Nov 2000, p. 10). Keywords: Molecular Diagnostics.

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1999

• (News) FDA to Offer One-Stop Regulatory Shopping (IVDT, Nov 1999, p. 12). Keywords: regulatory affairs.

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1996

• The special purpose reagents policy: A solution to the 10-year-old IUO/RUO dilemma?, Chris Zalesky (IVDT, Jan 1996, p. 28).

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1995

• OTC IVDs and drugs: Weighing the risks and benefits of their availability, Thomas Tsakeris (IVDT, Sep 1995, p. 26).
• Raising the standard: A critique of FDA's draft "points to consider" document, R. Michael Crompton (IVDT, Apr 1995, p. 10).
• Change to an existing IVD device: When to submit a 510(k), Thomas Tsakeris (IVDT, Feb 1995, p. 20).
• Commentary: Classification of immunohistochemical stains: A move in the right direction, Patricia Schrader (IVDT, Jan 1995, p. 14).

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