Articles

If you have suggestions for topics you would like to see covered by future articles or if you are interested in publishing an article in this section, please contact accureg@regulatory.com and reference "Articles". When submitting an article, please include your name and affiliation so we can credit you as author. All submissions will be reviewed by AccuReg's professional staff and are subject to approval prior to publication. We reserve the right to edit as necessary but will not publish a revised article without notifying the author and obtaining his/her approval.

Past Articles

Device Series:

• What Internally Discovered Defects Must Be Reported as MDRs by the Manufacturer?
• Special Report on Design Control Regulations by Kenneth F. Miles, PhD, RAC
• Special Report on Medical Device GMP Update at RAPS Annual Conference, September 10, 1996
• MDR: An Acronym for ManDatoRy by Larry Lepley, Lepley Consulting Group

Other Issues:

• The FDA Export Reform and Enhancement Act of 1996: A Step in the Right Direction
  by Alan G. Minsk, JD, of Arnall Golden & Gregory
• Good Development Practices (GDPs)
  by H. Ruth Pyle, RAC, and Loui J. Silvestri, PhD of AccuReg
• Validation of Analytical Assays and Test Methods for the Pharmaceutical Laboratory
• Short Report: FDA Public Hearing, November 16-17, 1995, "Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for the Structural Repair and Reconstruction"
• Special Report: "Recent Evolution of the Drug Regulatory Process," FDLI/FDA Satellite Video Conference, November 9, 1995
• Who Puts the 'c' in cGMPs?
• Outline for Developing a Requirements Traceability Matrix