Safety advocates say FDA guidance not enough

The FDA guidance to sniff for the contaminant TBA has been proven effective by Pfizer [see related story].  But some have begun to question the effectiveness of FDA guidance on the whole.

The food industry is currently reviewing a guidance proposal by the regulator aimed at minimizing safety hazards in fresh-cut fruit and vegetables. It provides recommendations on how to avoid product contamination via pathogens that can cause foodborne illnesses, reports Food Safety News.

That's not good enough, says Nancy Donley, president of a nonprofit for preventing illness from foodborne pathogens, in the article. Guidelines don't have any teeth, she says, and the FDA needs something stronger. "We need mandatory requirements. FDA has been operating under guidance documents for years, and it hasn't worked. Nothing has changed."

"[T]he time has long passed for voluntary guidance, no matter how well-meaning," adds attorney Bill Marler. 

- here's the article


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.