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More than 2,000 Minyard employees may see layoffs

BY Drew Buono

COPPELL, Texas Minyard Food Stores has sent a letter to the Texas Workforce Commission informing them of a layoff that will affect approximately 2,387 employees after the grocery retailer sells 37 stores, including its Carnival Super Market brand and other Minyard-owned stores to Grocers Supply, according to local reports.

The announcement, however, does not take into account the number of employees who most likely will be rehired by the new store owners after the sale is complete, a spokesman for Grocers Supply said.

Fiesta Mart, which will be taking over 11 of Minyard’s Carnival locations, is currently reaching out to affected employees and asking them to submit their applications for employment.

Minyard’s says the job cuts will officially start on Sept. 29 and end by Nov. 17. The Grocers Supply said by then, it hopes to have other retailers identified who will be taking over the operations of the remaining 26 stores.

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FDA approves Mylan’s generic Sular

BY DSN STAFF

PITTSBURGH The Food and Drug Administration has granted final approval to a Mylan hypertension drug, the company has announced.

The drug, nisoldipine extended release, is a generic version of Sciele Pharma’s drug Sular ER. The drug will be available in 20 mg, 30 mg and 40 mg strengths.

Sular had sales of about $94 million in the year ended March 31, according to Mylan. The ‘741 patent that protected Sular expired June 8.

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FDA adopts new policies for advisory committees

BY Drew Buono

WASHINGTON The Food and Drug Administration announced Monday that it has adopted several improved policies and procedures to strengthen management of FDA advisory committees.

The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures and improved disclosure processes related to advisory committee members and issues considered at their meetings.

Prior to each meeting, FDA staff will screen advisory committee members for potential financial conflicts of interest, such as grants, stock holdings and contracts with any company the committee’s recommendations would affect. The FDA is instituting a cap of $50,000 as the maximum financial interest an adviser may have in all companies a particular meeting might affect. Advisers with financial interests more than $50,000 will be excluded from the meeting. Advisers with interests of less than $50,000 may receive a waiver, but only if the FDA staff determine a need for their expertise.

The agency will also post briefing materials that committee members receive on the FDA’s Web site at least two days before the meeting.

In another improvement, the agency has issued guidelines regarding how committees vote on issues to avoid even the perception of vote manipulation, recommending that all members vote simultaneously.

The FDA also proposed new criteria to determine when it should refer a matter to a committee. In some instances, the law would require it. In others, the agency would consider the new criteria when deciding whether to refer a matter.

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