Medicine

Ensuring Drugs Are Safe and Effective : User Fees, Clinical Data
by Food and Drug Administration (FDA)
Since the Prescription Drug User Fee Act (PDUFA) was passed in 1992, more than 700 drugs and biologics have come to the market, including new medicines to treat cancer, AIDS, cardiovascular disease, and life-threatening infections.

Imported Drugs Safety : Re-Importation, Personal Use, Canada
by Food and Drug Administration (FDA)
The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug's original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real

Medications Available Without a Prescription : Part 3
by Food and Drug Administration (FDA)
Today's emphasis on self-care fuels the popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not substitute for a prescriber's medical knowledge.

Genomics and Personalized Medicine : Challenges
by Food and Drug Administration (FDA)
In 2002, the FDA held a workshop for industry on pharmacogenomics in drug development and regulatory decision making. 'The agency has taken a leadership role by initiating discussions about pharmacogenomics and gathering input on how the FDA can best

Truth in Drug Advertising : Guidance and Violations
by Food and Drug Administration (FDA)
Sometimes marketers combine help-seeking ads with perceptually similar reminder ads in a way that causes the audience to perceive the two pieces as one advertisement. Appearing individually, these ads are exempted by regulation from the risk disclosure

Drug Research and Children
by Food and Drug Administration (FDA)
Most drugs prescribed for children have not been tested in children. Only 20 percent to 30 percent of drugs approved by the FDA are labeled for pediatric use. So by necessity, doctors have routinely given drugs to children off label, which means the drug

Androstenedione: Andro Products Safety
by Food and Drug Administration (FDA)
People produce androstenedione naturally during the making of testosterone and estrogen. When people consume androstenedione, it is converted to testosterone and estrogen. Scientific evidence shows that when androstenedione is taken over time

Aspirin: A New Look at an Old Drug
by Food and Drug Administration (FDA)
Scientists continue to investigate what seem to be an unending number of possible new uses for the world's most widely used drug. There was a time when only one brand of aspirin existed, and its manufacturer's 1920s ad campaign was intended to assure

The Safety of Generic Drugs
by Food and Drug Administration (FDA)
By now, much of the nation has heard at least something about the Food and Drug Administration's investigation of the generic drug industry. The investigation has not only gripped the agency over the past several months, but also has had broad impact

On FDA's Front Lines: Investigators Protect Public
by Food and Drug Administration (FDA)
Responding to emergencies, as well as inspecting more than 90,000 establishments in this country, is part of FDA investigators' work. And there's no college in the world that can fully prepare them for it.

Adrenergic Bronchodilators
by Food and Drug Administration (FDA)
Inhalers that can alleviate the symptoms of asthma, chronic bronchitis, and emphysema are discussed in this continuation of a series on proper drug use. While they are not a cure for asthma, adrenergic bronchodilators can temporarily relieve the classic

Drug Therapies: Measuring Quality of Life, Lotronex Dilemma
by Food and Drug Administration (FDA)
The World Health Organization defined quality of life in its constitution in 1948 to include physical, mental, and social well-being, and not just the absence of disease or illness.

Camphor and Eucalyptus Oils
by Health Canada
Some health products that contain camphor and/or eucalyptus oils can cause serious health problems, including seizures, if they are accidentally swallowed by children. Health products containing camphor and/or eucalyptus oils

Drug Testing in Children
by Food and Drug Administration (FDA)
It's that children need medicines. Some drugs have already been well studied and approved for use in adults. To use one of these drugs for the same disease in children, it's important to figure out what doses work best in kids and what kinds of adverse

It began with a pill. One pill.
Bitter Pills: Inside the Hazardous World of Legal Drugs
by Stephen Fried
We take our medicines on faith. We assume our doctors are well-informed, our drug companies scrupulous, our FDA diligent--and our medications safe. All too often we're wrong.

Proper Use of Medications and Elderly
by Food and Drug Administration (FDA)
A brown paper bag may hold the key to safer use of medications, according to health experts. 'A brown bag checkup is the single best thing that patients can do to avoid medication mistakes and cut down on unnecessary medications,' says Douglas Paauw, M.D.

Equivalence of Generic Drugs : Part 2
by Food and Drug Administration (FDA)
In 1990, the agency instituted product-specific, pre-approval inspections of manufacturing sites listed in a sponsor's application. During inspections, FDA reviews the step-by-step manufacturing process and monitors how much and what kind of active

How to Protect Yourself Against Drug Tampering
by Food and Drug Administration (FDA)
Packaging has made tampering with over-the-counter drugs more difficult and more obvious. But consumers still need to look carefully at the package and the product. For years, most OTC drug products came in containers that were easy to open.

Buying Drugs over the Internet
by Health Canada
If you buy drugs on line, you may be putting your health at serious risk. This is especially true if you order prescription drugs without being examined in person by a health care practitioner.

Ensuring Drugs Are Safe and Effective
by Food and Drug Administration (FDA)
Here's how drug sponsors and the FDA make sure that new drug therapies are safe and that they do what they're supposed to do. The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route.