nonapproval

A spokeswoman for DePuy confirmed that the company had received the agency's so-called nonapproval letter.

NYT > Home Page By BARRY MEIER 2012

"But to get a 90% nonapproval rating was … really surprising."

Big Ten's New Look Not Winning Raves 2010

When we approve drugs, that is usually quite easy because we actually publish the articles … What is the most difficult situation is when we do not approve a drug, we are not allowed to talk about the nonapproval letter or the complete response letter and hence the American public in general is left in an ambiguous situation as far as why the action was taken that is a nonapproval action.

Excerpts From Pazdur Interview 2008

Third, we will include representatives of cancer patients in FDA's cancer advisory committees and thereby make sure that their views are heard when it comes to recommending approval or nonapproval of cancer drugs.

Briefing By Vice President And Dr Kessler ITY National Archives 1996

Only voting members could propose two persons a year to be nonvoting members'the stewards 'decision, approval or nonapproval being final, their voting secret.

Noble House Clavell, James 1981

Only voting members could propose two persons a year to be nonvoting members — the stewards 'decision, approval or nonapproval being final, their voting secret.

Noble House Clavell, James 1981

We have had no meetings on the question of approval or nonapproval and, as Mr. Barr has not had the courtesy to submit to us his reading list, we are not in a position to decide one way or the other.

Board of Visitors minutes 1951

I was informed this morning by Mr. Gooch that he understood that Dr. Snavely had said that the question of approval or nonapproval of Mr. Barr's course had been discussed in our faculty and that we had voted to approve.

Board of Visitors minutes 1951

William Vodra, a lawyer who specializes in F.D.A. regulation, said that, in general, drug and medical device makers typically disclose nonapproval letters if they might have a material impact on a company's finances.

NYT > Home Page By BARRY MEIER 2012

Also, a review of publicly available information indicates that the company did not discuss the agency's nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.

NYT > Home Page By BARRY MEIER 2012