Regulatory process and approvals

A regulatory framework and approval process was set up to avoid inadvertent release of material, to ensure environmental safety, and to protect the integrity of the plant product intended for food or animal feed. Much overlap exists between the agencies responsible for addressing these issues. 

Required reporting of changes in equipment, manufacturing processes, personnel establishment of formal quality control procedures and submission of samples for regulatory inspection and approval for release... 

An excellent example of a decision trees is shown in Figure 27.8. This example outlines the IND regulatory review and approval process. Similar decision trees are developed by project teams within the biopharma-ceutical industry. Project teams are now being asked not only to construct decision trees, but to develop contingency plans based on "what-if" scenarios far in advance of the next decision points. The goal is to ensure that the project will not lose forward motion in the event of a "no" decision that requires rework or another loop through the project cycle, or a decision by the PMT that resources for a particular project are more urgently needed for another project. 

Development of a pure isomer (in contrast to a racemic mixture) would markedly delay the development of a drug that may represent a breakthrough in the treatment of a life-threatening disease. The drug sponsor would then be expected to develop pharmacokinetic and pharmacodynamic data on both the racemic mixture and the individual isomers concurrent with the regulatory evaluation and approval process. 

There are of course many types of plant which process materials that are toxic, such as poisonous or radioactive substances, and corrosive fluids. Such types of plant invariably have a technology of their own, developed and proven to be adequate for the hazards involved, and any deviation from established plant designs or standard operating practices requires careful consideration, and possibly third-party or regulatory examination and approval. 

The entire process should be approved by the regulatory body, and approved also for consistency with other risks from natural and industrial... 

Regulatory approvals. These are delays associated with consent processes and approvals that arise from cumbersome decision-making processes and duplication of regulations. These types of delays are inherent in building and environmental legislation. 

This second edition is organized into twelve chapters. This edition updates information presented in the first edition, and adds two new chapters that discuss emerging issues that require more research but will likely play a larger role in our everyday lives in the near future (e.g., endocrine disrupters, nanotechnology, vapor intrusion see chapters 10 and 11), and the stringent regulatory process for approving new chemicals (see chapter 12). 

PMA requirements differ between preamendment and post-amendment devices. Preamendment devices are those in commercial distribution before May 28, 1976 post-amendment devices are those first commercially distributed after the date. Class III post-amendment devices that are not substantially equivalent to preamendment Class III devices are considered new devices. Manufacturers of such devices are required to obtain PMA appHcation approval before marketing these. If the post-amendment device is substantially equivalent to a preamendment device and PDA has not initiated a regulatory process specifically requiring the submission of a PMA for the device category, a 510(k) submission can be made. 

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