Medicine

Taking Aspirin To Avoid Heart Attack And Stroke
by Food and Drug Administration (FDA)
In recent years, you may have seen television ads promoting aspirin's ability to reduce the risk of heart attack and stroke in certain groups of people. You should know that deciding to take an aspirin a day is not as simple as it may seem.

Greater Access to Generic Drugs : Part 2
by Food and Drug Administration (FDA)
A stay is the term for the delay in generic approval that occurs when a brand-name company files a patent infringement lawsuit. This delay is meant to be a time to resolve issues about whether a generic drug company is infringing a drug patent.

Greater Access to Generic Drugs
by Food and Drug Administration (FDA)
Generic drugs are safe, effective, and cost less. The FDA has launched an initiative to encourage the availability of these alternatives to brand-name medications. Generic drugs are copies of brand-name drugs and are available in both over-the-counter

Careful with Pain Relievers
by Food and Drug Administration (FDA)
Experts urge care to avoid accidental overdosing and the risks for liver damage and other serious health problems. Acetaminophen is a safe and effective pain reliever that benefits millions of consumers.

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

The Advent of Food and Drug Regulation
by Food and Drug Administration (FDA)
One hundred years ago, government volunteers dined on carefully prepared foods laced with potentially poisonous preservatives in the interest of science.

Generic Drugs
by Food and Drug Administration (FDA)
Almost half of all prescriptions in the United States are filled with generic drugs. They are safe, effective, and FDA-approved. New drugs are developed by innovator firms.

Imported Drugs Safety : Internet Challenges
by Food and Drug Administration (FDA)
When it comes to buying prescription drugs online, Canada is dealing with some of the same regulatory challenges that occur in the United States. In May, the Ontario College of Pharmacists announced that it laid charges against The Canadian Drug Store

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

Imported Drugs Safety: Benefits of a Closed System
by Food and Drug Administration (FDA)
Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices. As part of the FDA's high standards, drugs can only be manufactured at plants

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.

Ensuring Drugs Are Safe and Effective : Accelerated Approval
by Food and Drug Administration (FDA)
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments.

Ensuring Drugs Are Safe and Effective : Reviewing Applications
by Food and Drug Administration (FDA)
Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor

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.

Why Drugs Get Pulled Off the Market : Risk Management Options Fail
by Food and Drug Administration (FDA)
The day you hear news about a drug coming off the market, it may appear to be a sudden, drastic step. But several other options to manage risks usually have been attempted before that point. The main risk management tools employed by the FDA are education

Why Drugs Get Pulled Off the Market : More Toxic than Expected, Safer Options
by Food and Drug Administration (FDA)
There are also times when a drug's toxicity is known, but the drug turns out to be more toxic than the clinical trials suggested, which again may only be seen when the drug is used in larger numbers or in different ways.

Why Drugs Get Pulled Off the Market
by Food and Drug Administration (FDA)
Most drugs on the market are well-tolerated and their adverse effects are known. Known side effects cause more injuries and deaths than unrecognized side effects. But some problems happen so infrequently that they can't be seen or predicted before a drug

Accutane Risk Management
by Food and Drug Administration (FDA)
FDA has announced changes that strengthen a risk management program regarding pregnancy and a drug used to treat severe acne. Accutane (isotretinoin) is a drug approved to treat the most serious form of acne - a type that is painful

Use Prescription Drugs Safely, Controlled Substances
by Food and Drug Administration (FDA)
The FDA has worked with Purdue to make specific changes to the OxyContin labeling. The new labeling is intended to change prescription practices, as well as increase the physicians' focus on the potential for abuse and misuse.

Prescription Drug Use and Abuse : There Is Help, Striking a Balance
by Food and Drug Administration (FDA)
Some treatments need to alleviate both withdrawal symptoms and the psychological addiction to drugs. Detoxification, the process by which the body recovers from tolerance and dependence, is considered a first stage in the sense that it purges drugs