Newsletter - April 21, 2016
How to Deal with Data Integrity Woes: New FDA’s Guidance to Help
Data integrity issues have plagued manufacturing sites in India for several years. Repeatedly GMP sites in India were found in violation of documentation practices, data manipulation, data omission, and other issues that raise major issues about reliability of data. Although sites in India are not alone in data integrity issues but arguably sites in India received more than their fair share of negative FDA audit findings because of data integrity issues. Read More..
Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?
Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of such dietary supplements are penalized despite laws that exist to do the same. Read More..
How to Deal with Data Integrity Woes: New FDA’s Guidance to Help
Data integrity issues have plagued manufacturing sites in India for several years. Repeatedly GMP sites in India were found in violation of documentation practices, data manipulation, data omission, and other issues that raise major issues about reliability of data. Although sites in India are not alone in data integrity issues but arguably sites in India received more than their fair share of negative FDA audit findings because of data integrity issues. Read More..
Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?
Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of such dietary supplements are penalized despite laws that exist to do the same. Read More..
