Bob Durkin Quoted in Natural Products Insider Article on Mystery of Drug Authorization Dates
AGG attorney and member of the firm’s Dietary Supplements team, Bob Durkin, was quoted in a Natural Products Insider article titled “Mystery of Drug Authorization Dates Poses Challenges for Natural Products Industry.”
The effective date of an investigational new drug application (“IND”) is critical as FDA interprets it as the race-to-market date between supplements and drugs. However, these dates are often a mystery to manufacturers of dietary ingredients and finished supplement products.
“Somebody’s effective date for an IND could be today, and you and I would have no idea about that,” said Bob. “Until there are publicly available documents, there’s no way for regulated industry, other than the IND holder, to know that an IND exists.”
To read the full article, please click here.
- Robert Durkin