Mandatory reporting

Figure 12.9 FDA form 3500A for mandatory reporting of adverse reactions.

Form FDA 3500A Mandatory reporting of adverse drug events by manufacturers Mandatory reporting of adverse device events by manufacturers, importers and device user facilities... 

Form VAERS-1 Mandatory reporting of Vaccine Adverse Events by manufacturers... 

Form FDA 1932 Mandatory reporting of Veterinary Adverse Drug Reactions, Lack of Effectiveness, or Product Defects by manufacturers... 

The forms used for expedited reporting of adverse events are listed in Table 12.2. An example of mandatory reporting form FDA3500A is shotvn in Figure 12.9. 

Reid WH, Keller S, Leatherman M, et al. ECT in Texas 19 months of mandatory reporting. J Clin Psychiatry 1998 59 8-13. 

Drug and alcohol problems are personal problems that can affect work performance significantly. Many states have mandatory reporting requirements... 

Class II Specified Persistent Mandatory reporting of planned and... 

Type 1 monitoring Persistent Mandatory reporting of actual amounts... 

Section 8 covers several topics including mandatory reporting on chemical production, use, and processing, the TSCA inventory itself, and how to handle allegations of adverse health and environmental effects of chemicals. 

Chasnoff, I. J., Landress, H. J., and Barrett, M. E., The prevalence of illicit drug or alcohol use during pregnancy and discrepancies in mandatory reporting in Pinellas County, Florida, N. Engl. f. Med., 322, 1202, 1990. 

Several types of data are routinely collected related to infectious disease surveillance, including morbidity, mortality, and health indicator data (CDC, 1992). Each state has requirements for mandatory reporting by health care providers and facilities, including laboratories, of cases of notifiable infectious diseases. There is a national notifiable disease list as well, for which reporting is voluntary, with data compiled through the National Notifiable Disease Surveillance System (CDC, 2004d, 2006). 

Industry challenges individual polluters Reduce resource depletion Multi-way active dialogue Life-cycle analysis Impacts and outcomes Global operating standards Corporate governance Mandatory reporting... 

An increasing number of countries are imposing requirements on companies to report on their environmental performance. Also, industry initiatives for voluntary reporting continue to appear. As mandatory reporting, or the threat of it, is such a... 

In conclusion, in reporting data of biota monitoring, the type of biota analysed and the species name are considered as mandatory reporting requirements in the template. 

When mandatory reportable diseases are encountered, they must be reported to the local Public Health Department, who will inform the CDC. 

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