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Medical Device & Diagnostic Industry
2001| 2000 | 1999 | 1998 | 1997 | 1996
2001
Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH (MDDI)
CDRH Ombudsman Weinstein details the responsibilities and initiatives of his position, and shares industry dispute and complaint statistics for the year 2000.
Shifting the Device Risk Burden (MDDI)
Does a recent device approval indicate a softening of FDA's "appropriate use" worries?
 
MX
 
1999
FDA in 2000: A Changing Regulatory Environment (MX)
Reengineered and modernized, FDA is striding forward into the post-Kessler era. To keep up, manufacturers will need to watch closely how the agency implements long-sought-after reform programs.
 
Pharmaceutical & Medical Packaging News
2001 | 2000 | 1999 | 1998
 
2001
FDA Clarifies Postapproval Changes (PMPN)
The agency has published a guidance document answering some of the most frequently asked questions on postapproval changes for drugs.
FDA Caters to Physicians (PMPN)
A proposed rule for redesigning prescription drug labeling can help save physician time and reduce adverse drug events.
 
IVD Technology
2001 | 2000 | 1999 | 1998 | 1997
 
2001
Closing the square (IVDT)
Just in time for the genetic product revolution, Bernard Statland brings a lifetime of IVD experience to FDA's Office of Device Evaluation.
Waived-complexity guidance enters comment period (IVDT)
When it comes to the simplest of IVD tests, it seems, nothing is simple.
 
European Medical Device Manufacturer
 
2001
Electronic Signatures Pose New Challenges for the Device Industry (EMDM)
US FDA's rule on electronic records and signatures (21 CFR Part 11) establishes the criteria under which the agency will consider electronic records and signatures equivalent to paper records and handwritten signatures. Complying with the rule, which became law in August 1997, raises regulatory, legal, and economic issues for device manufacturers. EMDM spoke with Valarie King-Bailey, vice president for global marketing at QUMAS (Cork, Ireland), about some of these issues facing OEMs in the digital age.
 
1997
MRA: Inching Toward a Unified Global Market (EMDM)
While most industry analysts applaud the recently initialled mutual recognition agreement, they caution that it should be viewed as a significant milestone on the road to harmonization, not the final destination.