Information provision questions

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

A properly written safety plan eontains worker health and safety program information, guidanee, and alternatives. The HASP should quiekly answer the two questions What hazards are present and What provisions have been made to make sure that all tasks will be performed safely [1] Subsequent ehapters will provide a detailed examination of a typieal HASP. The information presented will be generie and should be modified to fit any site-speeifie hazards. 

All too often, the Agency s proposals appeared to seek information for its own sake. As a result, EPA s reporting proposals often required the submission of data that are of questionable validity or limited relevance in EPA s risk assessment activities under other TSCA provisions. They also called for far more information than EPA had the capability to process and evaluate in a reasonable period of time. 

EPA s previous efforts to expand its authority would have resulted in the submission of data of questionable quality, and the imposition of unnecessary burdens on industry. Industry has recommended a more focused approach under which EPA could still obtain more than enough sound information to support its regulatory activities under TSCA. The reporting provisions of Section 8 are sufficiently broad to allow EPA to accomplish its objectives without departing from the basic statutory framework established by Congress. 

By common agreement, at the ICH SC meeting, all three parties would accept applications in the CTD format from 1 July 2001. This would be on a so-called voluntary basis, as the time required before implementation could become mandatory and vary according to the formal steps needed in the three regions. It was apparent that a question in the minds of many in the audience was whether the new format would really replace current requirements. At several points in the CTD, there is provision for authorities to ask for additional information according to regional requirements. ... 

Information should be provided in the form of a detailed summary in the ADRAC Blue Card format. Even if initial information is scanty, these details should be forwarded to the TGA pending receipt and provision of further data. This procedure should be followed even when the medicine in question is the subject of an application for registration and imder evaluation by the TGA. 

Some may question how the inspected laboratories rated in terms of comphance to each of the 141 operational provisions of the GLPs. The information accumulated from the Center for Drug Evaluation and Research indicates that 66% of the inspected laboratories were cited for one or more deviations from these provisions. The most significant departures from the GLPs were (1) final reports did not conform to the raw data (2) improper correction of the raw data (3) protocol revisions were implemented without amending the protocols (4) the absence of required SOPs and the failure to amend SOPs when necessary and (5) the master schedule sheets and the protocols did not contain the information required by the regulations. 

In 1997 the FDA again addressed the definitional question, issuing guidelines to clarify what constituted adequate provision for broadcast advertising. Under the new guidelines, drug broadcasts had to refer the audience to four sources to obtain further information ... 

Under Section 31 of the Therapeutic Goods Act, 1989, the TGA may make requests to sponsors for provision of additional information or seek clarification of information provided. Such requests are referred to as Section 31 requests or S31s. For applications in each of Category 1, 2 or 3, the time taken by sponsors to respond to the requests is excluded from the processing time in other words, the clock is stopped until the S31 is answered in full. The TGA also gives sponsors fixed times in which to respond to S31 requests, usually between 1 week and 2 months, depending on the complexity of the questions. 

The primary responsibility of any medical information department is the provision of product-specific information to healthcare professionals and/or consumers in response to specific inquiries. If a response to a question involves information outside the Food and Drug Administration (FDA)-approved package insert/labeling, the information is considered to be off label, and several factors limit the way in which information is communicated to the customer. 

The Commission has put a lot of work into guidelines - both formal and informal. But guidelines cannot go beyond the provisions of the Directive and hence cannot solve harmonisation issues that were left unsolved in the Directive. The discussions in Working Group 3 (WG3) under the Commission has served to some extent as a catalyst in soft harmonisation . One example of successful soft harmonisation was the question of whether or not banking of allowances between the first and second phase - i.e. from 2007 to 2008 - should be allowed. In other areas, soft harmonisation has not quite succeeded, but the discussions in WG3, workshops etc. have led to a degree of common understanding. Examples are the discussions of allocations to new entrants and on the scope of the Directive. These two subjects are discussed in further detail below. 

Knowledge from previous design projects can be reused in similar design tasks. Concerning the rationale aspect, a DPM contains information about constraints to be respected and questions to be posed which otherwise might be neglected or forgotten. A crucial issue for this kind of support is the provision of adequate retrieval mechanisms for relevant DPMs. 

Definitive information about the clinical effectiveness of DHA is important both for the patients and their families and for the scientific community. Provision of an unproven or ineffective therapy may provide a false sense of security and retard the introduction of new approaches and thus be counter to the patients best interests. Furthermore, there still are unresolved disputes about the optimal modes of DHA therapy. Which DHA preparation is most effective Should arachidonic acid supplementation be provided along with DHA Although at this time the titration of the DHA dosage is based on total levels of this substance in plasma and red blood cells, it is possible that follow-up of the levels of this fatty acid in specific lipid moieties might be more informative. Would it be effective and safe to increase the plasma DHA levels to higher than normal Carefully designed clinical trials are required to answer these questions. 

However, it is questionable whether these new concerns have been translated into an overall strengthening of the BW prohibition regime. On the multilateral level the Inter-Review Conference process has focused on a small number of selected issue areas in which a substantial amount of information has been produced by BWC states parties. However, to the extent that much of this information is related to domestic implementation of BWC provisions, these activities follow from BWC Article IV on national implementation. Yet, this stipulation of the BWC should have been followed by states parties three decades ago. So, at best the current exercise represents an attempt to catch up with BWC implementation as it is required under the Convention and as such could be providing a foundation on which to build future efforts to deal with the changing BW threat. 

EPA could require information on warning labels where there is evidence that the chemicals in question present an unreasonable risk and disclosure of confidential information is necessary to protect against that risk. It should be noted, however, that this provision imposes a high standard on EPA. The Agency must show not merely that a chemical poses an unreasonable risk but that the inclusion of confidential information in warning labels represents the only effective mechanism for controlling that risk and other approaches are inadequate. EPA probably could not meet this standard where users of a chemical would be adequately informed about potential risks by a generic description of the chemical s identity or where a description of the hazard posed by the chemical and appropriate precautionary instructions are adequate to assure its safe use. 

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