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The FDA for Doctors

Many doctors want to know more about the FDA not only so that they might better understand the issues and how they are related to their;

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Powerful Medicines

relationships between pharmaceutical companies, the FDA, and doctors, citing the detriments of drug promotions while arguing for a national agenda to;

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Food Safety, Fresh Produce & FDA Oversight

is of particular concern because produce is often consumed raw. The Food and Drug Administration (FDA) has primary responsibility for ensuring the safety;

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FDA Oversight of Medical Devices

The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally;

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FDA's Expedited Drug Programs

for the treatment of a serious condition, FDA may use one or more of its expedited programs, such as fast track and breakthrough therapy;

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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and;

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Drugs and the FDA

advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA;

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FDA Regulatory Affairs

demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA;

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FDA Foreign Offices & Imported Food Safety

The Food and Drug Administration (FDA) has a responsibility for ensuring the safety and proper labeling of more than 80 percent of the U.S;

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Health Myths Exposed

Health Myths Exposed marks the beginning of a war on deadly FDA-approved drugs and pharmaceutical industry campaigned health myths. In the;

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FDA Drug Approval

The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. market. Two regulatory frameworks;

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Tobacco Products

how FDA spent tobacco user fees for key activities using its authorities granted in the act, and any challenges FDA encountered in using its;

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Inside the FDA

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under;

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FDA Warning Letters About Food Products

products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the;

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Dietary Supplements

agency's ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location;

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Pediatric Drug Research & the FDA

Congress reauthorized two laws in 2007, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). PREA;

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FDA Review of Drug Applications

In the late 1980s, the median time for FDA to approve a new drug application (NDA) was 29 months. Industry, consumer groups, and FDA agreed;

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FDA Regulatory Affairs

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain;

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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market;

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Inside the FDA

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under;

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Hazardous to Our Health?

Some have described the Food and Drug Administration (FDA) as a scientific bureaucracy with police powers. Does a cult of infallibility;

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Fight for Your Health

Fight for Your Health: Exposing the FDA's Betrayal of America is a stunning exposé into the secret world of the FDA, Wall Street, and drug;

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FDA Regulation of Tobacco Products

products. In the mid-1990s, FDA claimed authority under the FFDCA to regulate cigarettes and smokeless tobacco products as delivery devices for;

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Drugs in Pregnancy

of common and less common drugs and provides for each drug the FDA letter categorization and newly approved Pregnancy and Lactation Labeling Rule;

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Drugs in Pregnancy

of common and less common drugs and provides for each drug the FDA letter categorization and newly approved Pregnancy and Lactation Labeling Rule;

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Drug Development & Rare Pediatric Diseases

affected by rare diseases and to encourage therapies for pediatric patients. During this same time period, the Food and Drug Administration (FDA;

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Food Labeling Compliance Review

-ROM are designed to aid in understanding the requirements of the FDA. Food Labeling Compliance Review is a must-have for regulatory officials;

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