United States approval process

Sucrose Esters. These newer emulsifiers, approved for direct addition in the United States in 1983 (35), ate formed when sucrose is combined with various fatty acids and the resulting emulsion is dehydrated. These additives are odorless and tasteless, and can withstand the retort process. They are used in products when standards of identity do not preclude their use, such as baked goods, baking mixes, dairy product analogues, fto2en dairy desserts and mixes, and whipped milk products (39). High price has limited use in the United States, but these compounds ate used extensively in Japan as emulsifiers in baked goods (40). 

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

A chlorination process (20,21,44—46) converts sucrose into sucralose [56038-13-2] (4,l, 6 -trichloro-4,l, 6 -trideoxy-galactosucrose), a heat-stable, noncariogenic, noncaloric, high intensity sweetener. Sucralose is approved for food use in Canada, Australia, and Russia. It is not yet approved for use in the United States. 

United States Spirits. The manufacture of distiUed spirits is tightly controUed within narrow limits that are specified in reference 2. ATE regulations require that a detailed statement of the production process be submitted for approval prior to placing any process in operation. 

Diet drugs that are in development take years to be approved and marketed in the United States. First, these compounds are studied in the laboratory. Then, they are tested in animals. The next step is to be tested in people. There are three rounds of study—called Phases 1,11, and III trials—to establish safety and effectiveness of the drug in humans. Drugs that are in Phase III trials are closest to approval and are usually available in the United States within a couple of years if they prove to be safe and effective. Drugs in Phase II trials are a little further behind in the approval process. 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

Large-scale processes for preparing bulk drug must be in place, with all the procedures required by the FDA and other sophisticated regulatory bodies satisfied. In the United States, the FDA must inspect the facility in which the drug will ultimately be manufactured (if if has nof already been inspected) to give final NDA approval. 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

In the United States the drug approval processes are as follows ... 

Formulation of dry powders for inhalation must rely on a very short list of excipients to fulfill the customary roles of diluent, stabilizer, solubilizer, processing aid, and property modifier (e.g., flow enhancer). In the United States, only a few materials are approved for use in inhalation products, and of those (e.g., propellants, surfactants) many are of little help in dry powder formulation. 

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