Recall, testing inquiry
This article was originally published in The Tan Sheet
Executive SummaryThe House Energy and Commerce Oversight and Investigations Subcommittee asks food firms about microbiological and chemical contamination during food processing. In May 8 letters, the subcommittee asks firms including Procter & Gamble and the Campbell Soup Company to list and explain their recalls and food safety alerts and, if applicable, list the contaminants involved. The subcommittee also asks for microbiological testing information that returned positive results, whether firms notified FDA if there was a chemical or contaminant issue and if and when the firms denied FDA or another regulatory agency access to records or facilities that involved testing methods. The committee asks firms to respond with domestic production information within two business weeks of receiving the letter, and to provide international production information within four weeks...
You may also be interested in...
The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.
FerGene bladder cancer therapy achieved a complete response in more than half of patients in its pivotal trial. The joint venture now looks to commercialization and potential expansion of indications.