Premarketing controls

Premarketing control of locally manufactured, imported, exported and sold pharmaceutical products. This part deals mainly with the issuance of ministerial notifications, setting up quality and standards, technical review, inspection and testing before approval and granting of licenses for pharmaceutical entrepreneurs and registration certificates of pharmaceutical products. 

Premarketing controls are specific to devices and device classifications. Premarketing controls for a medical device may include clearance to market by a 510(k) or approval to market by a PMA. 

In 1962, amendments to the U.S. Federal Food, Dmg and Cosmetic Act (Kefauver-Harris amendments) promulgated regulations concerning the requirements for premarketing approval by the FDA. This legislation estabUshed requirements of proof of both safety and therapeutic efficacy and strict control of human clinical testing, for example, which have extended the time and cost to market a new dmg. Thus, whereas approximately 40 new dmgs were marketed annually from 1948 to 1962, this number had fallen to 12 by 1966. 

Single-site IVD "Home brew" or "in-house" IVD made with an analyte specific reagent FDA requires labeling disclosing the "in-house" nature of the test but has no premarket review requirement CLIA requires analytical validation and quality control systems... 

Balazs, T.Jmmunogenetically controlled autoimmune reactions induced by mercury, gold and D-penicillamine in laboratory animals A review from the vantage point of premarketing safety studies. Toxicol. Ind. Health., 3, 331, 1987... 

The Medical Device Amendments pass to ensure safety and effectiveness of medical devices including diagnostic products, requiring some quality control, premarket approval, and performance standards on some products. 

Klein, A. W. and Schmidt-Bleek, F. 1982, Significance and Limitations of Environmental Compart-mentalization Models in the Control of New Chemicals Based on the Organization for Economic Cooperation and Development Minimum Premarketing Set of Data. In Modeling The Fate of Chemicals in the Aquatic Environment Dickson, K. L., Maki, A. W., Cairns, J. Jr., Eds. Ann Arbor Science Publishers Ann Arbor, MI. pp. 73-92. 

It is appropriate to recognize that some medications are more susceptible to abuse than others. If two medications are equally effective for a given indication, the one with lower abuse liability would obviously be preferred. Information on abuse liability is necessary for the appropriate regulation of medications and provides a basis for education of physicians, patients, and the public. In this chapter we describe the control of marketed medications, abuse-liability assessment procedures for premarketing testing in laboratory animals and humans, considerations of the formulation properties, and postmarketing surveillance of abuse. Finally, we provide three case studies of marketed medications that have been abused. 

This one costly human error had a considerable effect on the Congress, just then in the process of hammering out certain provisions of TSCA—The Toxic Substances Control Act of 1976. In particular those sections dealing with the premarket testing of hazardous chemicals, their labeling and distribution were affected (ref. 154). 

There are three types of premarket applications for new drugs. The most onerous is the full NDA, submitted under section 505(b)(1) of the FDC act [60]. A full NDA, in particular, requires extensive clinical data to prove the drug s safety and efficacy. FDA usually requires two adequate and well-controlled clinical studies to support approval [61]. The type of information that FDA will require for the NDA submission is described in the agency s regulations [62]. The law permits FDA to approve an NDA based on only one adequate and well-controlled clinical investigation and confirmatory evidence if certain conditions are met, however [63],... 

Franz R and Welle F, 1998, Submission CTS 59489 to US FDA, Division of Petition Control, HFS-215, Office of Premarket Approval. Washington DC, 1998 Results published in Deutsche Lebensm.-Rundschau 95 (10), 424-427. 

Steimer J, Mallet A, Mentre F (1985) Estimating interindividual pharmacokinetic variability. In Rowland M et aL (eds) Variability in Drug Therapy Description, Estimation and Control. Raven Press New York Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R (1995) Premarketing population pharmacokinetic study of levofloxacin in normal subjects and patients with infectious diseases. Biol Pharm Bull 18(2) 315-320... 

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