FDA To Review , Rules Regarding Manufacturing , Infant Formula .
On November 15, the United States Food and Drug Administration said it would review guidance and rules regarding the manufacturing of infant formula.
On November 15, the United States Food and Drug Administration said it would review guidance and rules regarding the manufacturing of infant formula.
Fox News reports that the decision is part of the U.S. health
regulator's strategy to prevent bacterial illness similar
to that found in Abbot Laboratories' products this year.
Fox News reports that the decision is part of the U.S. health
regulator's strategy to prevent bacterial illness similar
to that found in Abbot Laboratories' products this year.
The FDA will also reportedly weigh whether to establish a dedicated group of investigators to facilitate regulatory oversight of infant formula.
The regulator is considering realigning its
staff across two of its divisions to better
support oversight, among other new measures. .
The regulator is considering realigning its
staff across two of its divisions to better
support oversight, among other new measures. .
The announcement comes after a major
baby formula shortage earlier this year
that sent parents in the U.S. scrambling. .
The shortage was caused by a shutdown at Abbott's
Michigan plant after complaints of infection by
a bacteria known as cronobacter sakazakii.
The shortage was caused by a shutdown at Abbott's
Michigan plant after complaints of infection by
a bacteria known as cronobacter sakazakii.
Fox News reports that while the bacterial
infection is considered rare,
it can be deadly to newborns.
Abbott's baby formula products
were recalled after reports
of four cases and two deaths.
In September, the FDA said that its response
to the infant formula shortage was hampered
by delays and outdated technology.
In September, the FDA said that its response
to the infant formula shortage was hampered
by delays and outdated technology.
In a 10-page report, the FDA said that "inadequate processes and lack of clarity" related to whistleblower complaints could have slowed the agency's response.
In a 10-page report, the FDA said that "inadequate processes and lack of clarity" related to whistleblower complaints could have slowed the agency's response
