After a public hearing, the commission must make a decision on approval within the next 90 days.

The decisions on approvals for user-defined areas will be based on confidentiality concerns.

Again in 2013 an application has been filed for a Roadside Marker and awaits a decision on approval.

In any decision on approval, the provisions of Article 8 are applied to the specific case and the labelling arrangements and forms are defined.

The decision by the committee is non-binding and final decisions on approval of the drug are made by the FDA.

The company announced a smaller setback recently, when it said the F.D.A. would delay its decision on approval of Herceptin for early breast cancer by three months, until November.

The decisions on approval will often make or break a small company's stock price (e.g., Martha Stewart and Imclone), so the markets closely watch CDER's decisions.

Decision on approval of the decree of the President of the Russian Federation on the introduction of martial law by a majority vote of all members of the Federation Council and issued by decree.

After receipt of these comments, FDA will publish a notice in the Federal Register when the agency is submitting the collections to OMB for approval and again when OMB makes a decision on approval, modification or disapproval.

A major conference between the F.D.A. and the sponsoring company would be held right after the first phase of trials to plan a larger-than-normal second phase, which would enroll several hundred patients at numerous institutions and would be designed to answer all questions needed for a final decision on approval.

Currently, Mr. Hansen said, "the decision on approval of a generic drug is supposed to be made within six months after an application is filed, but it's not at all unusual for the process to take 14 to 16 months, which is longer than the time needed to approve many brand-name drugs."