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...
by Steven Perez | Sep 2, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links
FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets. The document also describes nomenclature and labeling, and is...
by Steven Perez | Jul 8, 2011 | Analytical Testing News & Updates | ADPEN Laboratories
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by Steven Perez | Jul 7, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links
This past May, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were...
by Steven Perez | Jul 7, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links
The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to...
