Approval process

The development of a new drug involves extensive preclinical (animal) and clinical (human) studies.19,21 The basic procedure for testing a new drug is outlined here and is summarized in Table 1-2. Details about the phases of drug testing can also be found on the FDA website (http //www.fda.gov/cder/handbook). 

Testing Phase Purpose Subjects Usual Time Period 

Preclinical testing Initial laboratory tests to determine drug effects and safety Laboratory animals 1-2 yrs 

Human (clinical) testing Phase 1 Determine effects, safe dosage, pharmacokinetics Small number ( 100) of healthy volunteers 1 yr 

Phase II Assess drug s effectiveness in treating a specific disease/disorder Limited number (200-300) patients with target disorder 2 yrs 

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Sucrose polyesters, which are made by esterilying sucrose with long-chain fatty acids, have the physical properties of fat, but are resistant to digestive enzymes (40). Olestra, a sucrose polyester developed by Procter Gamble, was submitted for regulatory approval in May 1987. In order to faciUtate the approval process, Procter Gamble has since narrowed the scope of its food additive petition to include olestra s use only in savory and extmded snacks. 

The U.S. Eood and Dmg Administration (EDA) approved 22 new dmgs and one biotech medicine during 1994. These new dmg entities had an adjusted average review time of 19.7 months, from filing of the New Dmg AppHcation (NDA) at the EDA to time of approval. This was down from the 25.6 months for the 26 new entities approval in 1993. In the total dmg development and approval process it takes approximately 12 years for an experimental... 

Regulating dmg quaHty is a federal concern that is reflected beyond the approval process. PDA has implemented extensive regulations to ensure that dmg products that are produced and marketed, as well as thek chemical constituents, continue to meet high standards of quaHty, purity, and safety, and have the identity and strength accurately represented. 

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA appHcation, require formal PDA approval through the PMA process before initial sale. The PMA process is comparable to the new dmg approval process (18). In both cases, safety and effectiveness data must be reviewed by PDA prior to marketing. An approved PMA appHcation acts like a private Hcense granted to the appHcant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

Until recently, the NRA has not participated during the approval process in assessing the potential environmental impact of pesticides. However, the NRA does supply monitoring data to MAFF and HSE for pesticide reviews. These occur once a pesticide has been approved for use for a certain length of time, or when further information is needed on an approved pesticide. In supplying these data, the NRA comments on any areas of concern. This contributed to the 1993 ban on the use of atrazine and simazine on non-cropped land. In January 1995 the NRA s National Centre for Toxic and Persistent Substances (TAPS) was made advisor to the DoF, on the potential impact on the aquatic environment of... 

The review and approval process for procedures for the toll needs to be clearly understood between the toller and their client. This can be addressed in the management of change system. A preliminary process or batch procedure may be written or proposed as part of the toller selection process or may be included in the initial... 

The issue that must be managed is the appropriate threshold to communicate the change and initiate appropriate approval processes. Tolls subject to regulatory requirements may use the regulatory guidance as the threshold for management of change processes other tolls must establish the threshold appropriate to process risks, quality systems, and business concerns. 

To be successful, a team selected from different groups within the project team should participate in the preparation and review of these plans. In addition, a schedule of the review and approval process for these plans needs to be established, accepted by all reviewers, and distributed before release of the first draft. Reviewers should meet an established schedule for review and submission of comments. A distinction between review and approval authority should be determined. The review process determines if all of the required elements are identified. This review can take considerable time, depending on the complexity of the project. The approval process is important when all comments are incorporated. The key responsible persons associated with the project should accept and approve the changes to the document. 

The product approval process, or PPAP as it is known in QS-9000, is intended to validate that products made from production materials, tools, and processes meet the customer s engineering requirements and that the production process has the potential to produce product meeting these requirements during an actual production run at the quoted production rate. 

The standard requires the supplier to apply the product approval process to subcontractors. 

The standard requires maintenance of equipment to ensure continuing process capability in clause 4.9.1(g) and in clause 4.9.3 requires the supplier to maintain or exceed process capability or performance as approved via customer part approval process. 

Production part approval process (PPAP) (GM, Ford, Chrysler)... 

Once the plan is complete, you will almost certainly need to submit it for final approval. Your company probably has well established approval processes. Make sure to understand these and adequately brief anyone who may present your project to project review committees or board meetings on your behalf. When preparing your plan for approval, it is important to briefly reiterate the history of the project. Although you have thoroughly prepared senior management through your various communication and consultation exercises, they will not recall all of the relevant background. 

Throughout the approval process, work with your senior champions to make sure they have the information they need to keep the project moving. Listen for the sounds of opposition and move to defuse any issues that may obstruct the project. Don t assume no news is good news. Bad news is difficult to deliver if you expected to hear something on a particular day and didn t, you should call and find out what is happening ... 

In 1985, Uie Cimadian Chemical Producers Association (CCPA) released a pampWet entitled, "Essential Components of Safety Assessment Systems . Modifications to process or plant was one of the topics discussed in Uiis pamplilet. CCPA recommended a 12 element program (listed below) to formally e.xamine and approve process conditions whellier permanent or temporary prior to implementation. 

The pre-market approval process is a considerably more complex procedure, as the FDA can only grant marketing approval on the basis of an assessment of the actual safety and effectiveness of the device in question. Thus, it is similar to a drug... 

Part 71 Color additive petitions — These regulations describe the pre-market approval process for new color additives or new uses for listed color additives. ... 

The NADA method approval process consists of three phases (1) method development by the sponsor and generation of information to establish that the method satisfies acceptability criteria (2) FDA review of the sponsor s data to determine suitability of the method and (3) the method trial , an inter-laboratory study, which determine whether the method meets performance criteria when used in multiple laboratories. The inter-laboratory method trial procedure provides an indication of a method s ability to be used as a practicable and reliable regulatory tool. Sponsors are urged to develop methods that are mgged and exceed rather than meet the minimal standards of acceptability. Those methods that appear marginally acceptable after review often do not pass the inter-laboratory method trial. 

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