Regulatory Endorsement

The qualification of novel DILI biomarkers will require application to biospecimens obtained from many different patient populations treated with many different drugs, both those that cause clinically important DILI and those that cause elevations in traditional liver chemistries but do not cause clinically important liver injury. It is important that pharmaceutical companies start now to archive samples and link these specimens to the relevant liver safety data. Ideally, liver safety data management tools should be standardized across the industry to facilitate the precompetitive collaborations on biomarker validation and qualification, such as eDISH (Watkins et al., 2011). Formal biomarker validation and qualification will warrant significant time to obtain regulatory-endorsed exploratory status via Letters of Support. 

New regulatory initiatives (e.g., from OSHA and EPA) and industry programs (e.g., the Chemical Manufacturers Association s Responsible Cate effort) have stimulated increased attention to PSM. While compliance is certainly a requirement in deciding to implement PSM, it is by no means the only ben t. Rather, compliance is the baseline from which other benefits evolve. The quality and effectiveness of the system your company ultimately adopts could well depend on how persuasively those benefits are conveyed. Remember, at this point in your initiative, the goal is to win endorsement of a concept, not approval of a full-fledged plan. The core of that concept is the idea that PSM offers benefits over and above compliance with new regulations, or conformance with an industry initiative. 

You will be exporting, importing, and creating data for these models, so it is important that you learn about them. The FDA has begun to formally endorse the use of these data models in their guidance. Eventually the FDA will probably require data to be formatted to the CDISC model standards for regulatory submissions. 

At the 17th meeting of the ECVAM Scientific Advisory Committee in 2001, the EST, the MM assay, and the WEC assay were endorsed as scientifically validated assays and ready for consideration for regulatory acceptance. Detailed reports on the performance of these validated assays have been published (5-7). 

The best demonstration of success for the GHTF will be the incorporation of the GHTF-endorsed harmonized requirements into existing regulatory systems by the various national competent authorities. 

The review and approval of the plan by QA is optional, but will provide an endorsement that the plan conforms to the current written procedures on computer systems validation, and that the document incorporates applicable regulatory requirements. 

It is not NCRP s intent to recommend specific boundaries between waste classes. Rather, the examples illustrate that the recommended framework has the potential to be practical and to result in an implementable waste classification system when a variety of plausible assumptions are used. Many assumptions are made in developing the examples. NCRP endorsement or disapproval should not be construed from the use or absence of specific assumptions about exposure scenarios and allowable doses or risks. It is the responsibility of the appropriate regulatory authorities to develop and guide implementation of any waste classification system. 

Once an equivalent authority receives an inspection report from another equivalent authority (post- or preapproval reports), the receiving authority will normally endorse the report, except under specific and delineated circumstances (e.g., material inconsistencies or inadequacies in inspection report, quality defects identified in postmarket surveillance, and specific evidence of serious concern in relation to product quality or consumer safety [39]. In these exceptional cases, the importing country s regulatory authority may request clarification from the exporting country, which could result in a request for reinspection. In addition, the importing country might conduct its own inspection of the production facility if attempts at clarification are not successful [40]. 

Fundamentally, REACH is spurring the international acceptance of new risk assessment procedures, such as the use of in-silico methodologies. From a risk management perspective, regulatory agreement at the EU level can also provide a strong political force for action at an international level. As the only internationally endorsed RRS guidance is based on the current EU document... 

Pharmaceutical and healthcare companies are obliged to determine the suitability of proposed suppliers providing products and services, particularly those providing software. Regulatory authorities neither prohibit or endorse specific systems despite what some supplier marketing might suggest. 

The Handbook of Pharmaceutical Excipients is a reference work containing a compilation of information on the uses and properties of pharmaceutical excipients, and the reader is assumed to possess the necessary knowledge to interpret the information that the Handbook contains. The Handbook of Pharmaceutical Excipients has no official status and there is no intent, implied or otherwise, that any of the information presented should constitute standards for the substances. The inclusion of an excipient, or a description of its use in a particular application, is not intended as an endorsement of that excipient or application. Similarly, reports of incompatibilities or adverse reactions to an excipient, in a particular application, may not necessarily prevent its use in other applications. Formulators should perform suitable experimental studies to satisfy themselves and regulatory bodies that a formulation is efficacious and safe to use. 

The CIOMS I working party s efforts were highly effective. Today, every regulatory authority in the developed world has endorsed expedited SAE reporting, usually within 15 working days of receipt by the company. The CIOMS form, in its later editions, is also now ubiquitous. 

The issues involved in the necessary record keeping. Good manufacturing practice (GMP) and regulatory control that are associated with a seeded process in the pharmaceutical industry are sometimes cited as reasons not to seed. In response to an article endorsing this premise (Pessler 1997), the following rebuttal by C.B. Rosas (personal communication) summarizes his and the authors views on this topic. 

Step 4. The final draft is endorsed by the steering committee, which recommends adoption by the three regulatory bodies. 

The water pollution debate was renewed in 1940, and in that year the effort to enact a national system of environmental controls reached a high-water mark that would not be revisited until the 1970s. A revised version of the Barkley bill, with the objectionable budgeting clauses excised, first passed the Senate. In the House, an amendment adding federal regulatory authority over new pollution sources was offered. Roosevelt altered course to endorse regulation, and the amendment was adopted. But in conference committee the House and Senate each insisted on its own position, and the bill died.17... 

From the very early days of irradiation sterilization, the major regulatory bodies have not demanded pharmacopoeia sterility testing of irradiated finished products. This has been an endorsement of the effectiveness and the levels of... 

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