by Steven Perez | Oct 3, 2011 | All Services, Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links
Last week, FDA published a guidance titled Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency’s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter...
by Steven Perez | Oct 3, 2011 | All Services, Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links, Pharmaceutical Links
FDA’s 2011 Process Validation: General Principles and Practices guidance created a systemic shift in industry’s approaches to validation programs. The authors describe the three-stage approach to validation that is outlined in the new guidance and discuss...