Sentence examples for approval of compounds from inspiring English sources

Spurred by the NIMH Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative, a pathway for FDA approval of compounds to improve cognition is being established including an approved battery of tests, the MATRICS Consensus Cognitive Battery (MCCB), and numerous clinical trials are underway to identify new treatments.

For clinical studies, this may lead to a shorter duration of trials, improved cost-effectiveness and faster approval of compounds by the regulatory agencies.

The move will delay any potential bid for approval of the compound, which the companies had planned to submit to federal regulators in 2004, Ms. Fox said.

This information may in turn contribute to the design of more efficient clinical trials and thus expedite the development and regulatory approval of newer antipsychotic compounds.

Section 505 j) sets forth the process by which the producer of a generic drug that is identical to a previously approved product can file an Abbreviated New Drug Application (ANDA) to seek FDA approval of the generic compound.

"Continuing to compound this product after FDA approval of Makena renders the compounded product subject to FDA enforcement for violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance," the letter says.

Where the legal definition of an approved active substance includes different varieties of a parent compound or where the approval applies to a defined group of compounds, these were counted as a single entity.

"I think we have a pipeline today that is probably as rich a drug pipeline as we've ever had," Mr. Weldon said, adding that the company plans to file applications for Food and Drug Administration approval of 7 to 10 new compounds from 2008 to 2010.

In the United States, sales of compounds for public use are subject to some form of regulation and approval by several statutes enforced by the EPA and other agencies.

The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval.

Among the billions of compounds that has been synthesized and tested to date, only a fraction of them has the potential to pass through the FDA approval.