Regulatory agencies FDA

Presented together by the British, European, Japanese, and U S. Pharmacopeias, the first Interpharmacopeial Open Conference on Standards for Excipients was convened in Orlando, FL, from January 30-February 1, 1991 (Table 1). Attended by 165 participants, representation included 11 countries, 59 pharmaceutical or excipient manufacturers or suppliers, three regulatory agencies (FDA, EEC, and HPB), and seven pharmacopeias (the presenters and the French, Italian, and Spanish Pharmacopeias) [17]. In preparation for this conference, USP convened open meetings on Magnesium Stearate and Lactose attended by almost every major manufacturer from Europe and the United States. 

Extractability tests prescribed by other regulatory agencies [FDA, Parenteral Drug Association (PDA)] for closures for drug packaging [69,70] are also limited to the amount of extractable residues or tests to evaluate the in vivo reaction of the extractable residue when the material fails in the in vitro tests. 

Levels of process and product-related impurities must be within safety limits established by international regulatory agencies FDA (http //www.fda.gov), EMEA fhttn //www.eudra.orgl and WHO (http //www.who.intl. which thus require the development of sensitive and validated quantitative methods from manufacturers. Major impurities are often product-related impurities while minor impurities are generally process-related impurities. 

The committee is confident that this report will provide regulatory agencies—FDA, Health Canada, and others—with the recommendations, tools, and resources required to improve guidelines to ensure the safety of infant formulas for generations to come. 

Because the conclusions that can be reached from an LSMBS depend critically on the choice of commodities, involvement of relevant regulatory agencies [e.g., EPA, USDA, and Food and Drug Administration (FDA)] in the USA, depending on the commodity and study objective] should be considered. Agreement on the choice of commodities by such authorities will ensure that the study and its outcome will be acceptable for regulatory purposes. 

In our meta-analysis, more than half of the clinical trials submitted to the FDA showed no difference between drug and placebo. Most reviewers of the clinical-trials literature have not had access to unpublished studies and may not even know of their existence. But the FDA and other regulatory agencies around the world knew of these data. Nevertheless, their existence is not even mentioned in the product labels, information leaflets and official Summaries of Product Characteristics (SPC) of most antidepressants. 

It is possible to interact with the various regulatory agencies (particularly the FDA) when peculiarities of science or technology leave one with an unclear understanding of what testing is required. It is best if such discussions directly involve the scientists who understand the problems, and it is essential that the scientists at the FDA be approached with a course of action (along with its rationale) that has been proposed to the agency in advance. 

The FDA (and similar regulatory agencies, as reviewed by Daniels et al., 1997) has become increasingly concerned with the safety of stereoisomeric or chiral drugs. Stereoisomers are molecules that are identical to one another in terms of atomic... 

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