The Annual Report

Although not legally required to do so, every publicly held company publishes an impressive-looking annual report at the end of each calendar year or fiscal year. This report, which is written primarily for stockholders, but is available to other interested parties, usually provides the following useful information  

Summary of concerns that might influence the company s business. 

The current financial condition of a company can be assessed by an analysis of the financial statements in the annual report. The latest annual reports of more than 3,600 U.S. companies can be obtained free of charge from PRARS (The Public Register s Annual Report Service) from their Web site at www.prars.com. 

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The annual reporting requirements to the US Securities and Exchange Commission (SEC) legally oblige listed oil companies to state their proven reserves. 

Periodical summaries of recent knowledge are to be found in the Annual Reports on the Progress of Chemistry (issued annually by the Chemical Society, London), Quarterly Reviews (issued quarterly by the Chemical Society, London), and in Chemical Reviews. 

The Annual Report of the Chief Medical Officer of the Department of Flealth, On the State of The Pnblic Health, FIMSO, London, 1992. 

Make sure you review all of these if your customers discover that you haven t read the Annual Report, your credibility may be ruined ... 

Marketing forecasts for batteries have been compiled from the Annual Reports published by several battery companies. Information based on the trade journals and investor s brochures, which surveyed and evaluated the present and future global distribution of battery types, was collected. Points of interest were the availability of batteries and their performance/cost ratios, but also geographical usage in connection with social considerations, such as per-... 

Dmg regulatory authorities in each of the countries produce an annual or quarterly report, the contents of which vary. The study in Cyprus specifically pointed out that the annual reports of its DRA are mostly activity reports, with no comments about the extent to which the set objectives have been achieved. 

CFR - Part 312.33 discusses what is required for an Investigational New Drug (IND) application. Part 312.33 discusses the requirements for the annual reporting for the IND. This reporting requires you to create adverse event, death, and subject dropout summaries annually for any drug under an IND application. 

In the annual report of the British Columbia Botanical Office in Vancouver for 1914, prepared by the Provincial Botanist in charge, John Davidson, there appears an illustration, here reproduced (Fig. 1), showing a branch of Douglas fir laden with white masses of a sugar-like substance the photograph was prepared from specimens received by the Office from its correspondent James A. Teit, of Spence s Bridge, British Columbia, who, in connection with his ethnological work on the plants... 

In addition to the Annual Reports on NMR Spectroscopy monograph reviewing H-NMR and, 3C-NMR spectroscopy of alkaloids in three volumes (305), several books and reviews appeared concerning the 13C-NMR spectroscopy of naturally occurring substances (306-308). Therefore we would like to present only a limited number of examples of the exceptional applicability of these physical methods for structure elucidation and conformational analysis of complex molecules. 

Technical. Additional technical support in companies other than testing personnel will arise from the need for additional recordkeeping, such as the annual reports and TSCA inventory ( 8(a) and (b)), records of significant adverse reactions to health or environment ( 8(c)), records of applicable health and safety studies ( 8(d)), and notices of substantial risk to health or environment ( 8(e)). In larger... 

Concluding Remarks One of the most important sections of an annual report is the "notes. These contain any liabilities that a company may have due to impending litigation that could result in charges or expenses not included)in the annual report. 

The chemical should not contain any chemicals that are a carcinogen or that are known to cause reproductive toxicity. Carcinogens are defined as those chemicals listed in the current edition of the Annual Report on Carcinogens, U.S. Department of Health and Human Services, National Toxicology Program. Chemicals known to cause reproductive toxicity, for example, are defined as those hsted by the state of California under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Cah-fomia Code of Regulations, Title 22, Division 2, Subdivision 1, Chapter 3, Sections 1200, et seq.)... 

Chemistry—Application/compendial release requirements and stability testing. For stability testing, one batch should be on long-term stability testing with data being reported in the annual report. 

Filing documentation—All information must be included in the annual report (including long-term stabihty data). 

Filing documentation—A prior approval supplement with all data including the accelerated stability data is required. This change should also be documented in the annual report along with the long-term stability data. 

Information available—One batch with three months accelerated stability data reported in a supplement and one batch on long-term stability reported in the annual report. 

Chemistry—Identify location of new site and updated batch records. No other documentation is required beyond application/compendial release requirements, although one batch produced at the new site should be placed on long-term stability and the data should be reported in the annual report. Dissolution data other than normal release requirements are not required nor is in vivo bioequivalence testing required. 

Filing documentation required—Changes being effected should be identihed in a supplement. Long-term stability data are reported in the annual report. 

Filing documentation—Prior approval supplement with justification for change long-term stability data must be reported in the annual report. 

Filing documentation—A prior approval supplement must be filed with justification for the change. Long-term stability data should be submitted in the annual report. 

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