by Steven Perez | Oct 20, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links
Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers (PCIDs) in solid oral dosage forms as an anticounterfeiting strategy. The guidance defines a PCID as “a substance or combination of...
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...
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 | May 26, 2010 | Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links
Nitrofurans are a class of drugs that have the ability to kill micro-organisms. The group consists of four drugs. Since 1989, nitrofurazone has been discontinued from being classified as a drug by the US Food and Drug Administration. It has been reported that most...
