product approval

No amount of good news - even product approvals - could move them.

Previously, many emerging countries did not require local trials for product approvals.

The register gives details of product approval, revocation and withdrawal.

Another important question is the liability of the Member States in connection with decisions on product approval.

Issues such as product approval, producer licensing and group supervision all generated healthy debate.

We have been advocating a reduction in the use of animals in research, science and product approval.

Their efforts have raised the possibility that the cosmetics industry eventually could be subject to greater government regulation, with perhaps mandatory testing and product approval.

Biotechnology stocks shook off a three-year stupor, helped by new product approvals.

The Agreement is to be supported provided the product approval procedures become shorter and simpler without compromising on safety standards.

A string of major product approvals by the Food and Drug Administration has focused investor attention on these companies.

Specifically, the terms safe and effective might not be synonymous with the FDA-defined legal standards for product approval.

It should be noted that with this Agreement's entry into force product approval and licensing procedures will become more flexible, shorter and cheaper.

Millions will be saved through product approval procedures and mutual acceptance of shorter, simpler and cheaper certification findings.

Such studies are necessary to resolve final design issues before the device is ready for a large clinical trial that is typically required for product approval.

Newer pre-engineered sunroom designs must meet strict criteria to obtain building permits and product approvals through various agencies.

The head office, based in Wellington, New Zealand, handles "centralised administrative functions, product approval, and standard settings."

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

The removal of the de facto moratorium for product approvals is the precondition for more planning security for companies and the agricultural sector.

In the area of drugs, the law codifies the agency's current practice of allowing in certain circumstances one clinical investigation as the basis for product approval.

Data exclusivity extends from the date of product approval, and this protection period runs concurrently with any remaining patent term protection for the biologic.

What is new, analysts say, is a corresponding excellence in navigating the political and regulatory shoals that lay between drug development and product approvals.

The service is free and available for a wide variety of FDA's Web pages, including food safety protection, medical product approvals and consumer health information.

"There have been a number of product approvals which are showing the world that the industry has not lost its capacity to innovate," Mr. Taurel said.

Instead, she trains senior management preparing for product approvals and withdrawals, manufacturing shutdowns, employee layoffs, educational campaigns and even videoconferencing.

Product Approval Information U.S. Food and Drug Administration (FDA)