Positive approval

Positive Approvals. Certain product groups are required to meet demanding approval regimes. These include ... 

A possible location for an additional X-cap is directly on the prongs of the inlet socket (at the entrance to the power supply). We remember that in this position any line-to-line capacitor will be exposed to a huge current surge at power-up, and could degrade, if not fail immediately. So if this X-cap position seems to be the last resort, it should at least be made as small as possible (typically 0.047 iF to 0.1 < I ). Or we can try ceramic capacitors in this position (approved ceramic X-caps or Y-caps should be tried here). 

On the basis of positive results of the procedure attestation the statement about the possibility for use of the developed procedure is issued and approved in prescribed manner. 

Production and Shipment. Estimated adiponitrile production capacities in the U.S. in 1992 were about 625 thousand metric tons and worldwide capacity was in excess of lO metric tons. The DOT/IMO classification for adiponitrile is class 6.1 hazard, UN No. 2205. It requires a POISON label on all containers and is in packing group III. Approved materials of constmction for shipping, storage, and associated transportation equipment are carbon steel and type 316 stainless steel. Either centrifugal or positive displacement pumps may be used. Carbon dioxide or chemical-foam fire extinguishers should be used. There are no specifications for commercial adiponitrile. The typical composition is 99.5 wt % adiponitrile. Impurities that may be present depend on the method of manufacture, and thus, vary depending on the source. 

There is a health benefit associated with hindering hydrogen bonding. Alkylphenols as a class are generally regarded as corrosive health hazards, but this corrosivity is eliminated when the hydroxyl group is flanked by bulky substituents in the ortho positions. In fact, hindered phenols as a class of compounds are utilized as antioxidants in plastics with FDA approval for indirect food contact. 

Personal Protective Equipment. Personal protective and emergency safety equipment should not be reHed on as the primary protection from aHyl chloride. Prevention of exposure should be considered the preferred precautionary measure. Where the exposure guideline may be gready exceeded, an approved positive-pressure air suppHed or self-contained breathing apparatus with fuH facepiece should be used (51). 

The change does not need to be reviewed and approved by the same individuals who reviewed and approved the original document. The important factor is that the same functions or organizations review and approve the change. The reason is to subject the document to the same scrutiny as the original by personnel as qualified as those who examined the original. Providing your procedures specify the review and approval authorities in terms of functions or positions and not names, the requirement is easily satisfied. 

The standard requires purchasing documents to include, where applicable, the title or other positive identification, and applicable issue of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. 

In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full facepiece operated in the pressure demand or other positive pressure mode... 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

The subcutaneous dose of interferon alfa-2b (Intron A) in patients who are HBsAg-positive is either 5 million units daily (better tolerated) or 10 million units three times weekly. The dose for HBsAg-negative patients is 5 to 6 million units three times weekly. The approved dose for pegylated interferon alfa-2a (Pegasys) for chronic hepatitis B is 180 meg subcutaneously once weekly. Interferon doses may need to be adjusted in patients with renal impairment. 

For treating outpatient CAP, two antibiotics are approved for a 5-day duration of therapy, levofloxacin (the 750-mg dose) and azithromycin. The duration of therapy for all other therapies is 7 to 10 days. For treatment of CAP in patients admitted to the hospital, the duration depends on whether or not blood cultures were positive. In the absence of positive blood cultures, the duration of therapy is 7 to 10 days. If blood cultures were positive, then the duration of therapy should be 2 weeks from the day blood cultures first became negative. 

Azithromycin and clarithromycin have shown some success for cryptosporidiosis, even in HIV-positive patients.4 However, the most promising agent is nitazoxanide, which was approved recently by the FDA for the treatment of cryptosporidiosis in children. In randomized, placebo-controlled trials, nitazoxanide has demonstrated efficacy in cryptosporidiosis in immunocompetent persons, malnourished children, and HIV/AIDS patients with CD4+ cell counts above 50 cells/mm3.39 Limited evidence suggests that patients with CD4+ cell counts of less than 50 cells/mm3 may benefit from higher doses, longer durations, or both.39... 

Fulvestrant is a new agent approved for the second-line therapy of postmenopausal metastatic breast cancer patients who have tumors that are hormone-receptor-positive. Studies examining the role of fulvestrant in the treatment of metastatic breast cancer have compared this agent with anastrozole. Given anas-trozole s mechanism of action, only postmenopausal women were eligible for these trials. There is no biologic reason why fulvestrant should not produce similar outcomes in premenopausal... 

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