Medicine

User Fees to Fund Faster Reviews : Part 2
by Food and Drug Administration (FDA)
The idea of FDA user fees resurfaced beginning in 1982 but failed to gain significant support. In 1992, things changed. As budget proceedings for FY 1993 began, FDA Commissioner David A. Kessler, M.D., testified before Congress that the user fee issue was

User Fees to Fund Faster Reviews
by Food and Drug Administration (FDA)
An average of 22 months goes by from the time a company applies for approval to market a new drug or biologic application to when FDA reaches a decision. But that's about to change, thanks to a new source of revenue to expand FDA's review staff.

Ways to Speed Treatments to Patients : Part 3
by Food and Drug Administration (FDA)
FDA and sponsors of priority drugs may meet at the earliest stages of clinical testing to plan studies that will help develop the information necessary for a final decision on a product's approvability.

Ways to Speed Treatments to Patients
by Food and Drug Administration (FDA)
In an effort to help seriously ill people, FDA is devising new ways to get drugs and biologics to them more quickly--sometimes even before final approval.

Medicines from Space : Part 3
by Food and Drug Administration (FDA)
One NASA spinoff comes from work on the motion sickness astronauts experience. Drug injections are impractical, since the medications may froth under weightlessness. Vomiting can make the use of oral medications also unworkable.

Medicines from Space : Part 2
by Food and Drug Administration (FDA)
Other phenomena occur more slowly in space than on Earth. One example is the growth of protein crystals from biological cells, which are important in the development of treatments for cancer, AIDS and diabetes.

Medicines from Space
by Food and Drug Administration (FDA)
Experience and experiments on space flights are yielding answers for treating earthly ills, from osteoporosis to diabetes to abnormal blood pressure. A principal objection to space manufacturing is the expense of transporting products back to Earth

Just What Is a Biologic, Anyway?
by Food and Drug Administration (FDA)
It used to be that most common biological products were vaccines and blood products. But today, the emergence of biologics with drug-like actions and other uses have made the answer to this question more complicated.

Smart Drugs and Drink May Not Be Smart
by Food and Drug Administration (FDA)
Young professionals in some parts of the country are turning to so- called smart drugs and drinks in an effort to be hip or get ahead. But there's no evidence that they work, and they may be harmful.

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

Equivalence of Generic Drugs
by Food and Drug Administration (FDA)
After a scandal rocked the generic drug industry, FDA tightened up its regulation of the manufacture of medications that duplicate brand-name products but usually cost much less. Although not all approved drugs are available in a generic version

On FDA's Front Lines : Part Cop, Part Counselor
by Food and Drug Administration (FDA)
In fact, the oxygen repacker MacLaughlin inspected was in Richmond. FDA has five investigators in Richmond, but one was preparing for a three-week assignment inspecting European drug firms, another was handling seafood inspections, and the other three

On FDA's Front Lines : Trust and Verify, Making the Grade
by Food and Drug Administration (FDA)
How do investigators get this proof? First they observe actual manufacturing practices to see if the process is being done correctly and according to the company's and FDA's manufacturing standards.

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.

When Do You Need an Antacid?
by Food and Drug Administration (FDA)
Used according to directions and in moderation, over-the-counter antacids can help relieve occasional heartburn and indigestion symptoms. But improper use can cause irreparable harm to your heart, kidneys or bones.

Teens: Using Over-the-Counter Medications Wisely
by Food and Drug Administration (FDA)
Medicines you can buy without a prescription need to be taken with the same cure as those a doctor prescribes. And teenagers looking for help for chickenpox or flu need to be especially aware of the ingredients in the products they buy.

How to Protect Yourself Against Drug Tampering : Part 2
by Food and Drug Administration (FDA)
But while FDA laid down the law concerning tamper-resistant features, its regulations stress that these features cannot prevent tampering; they simply help to alert the consumer if tampering has occurred.

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.

New Ways to Deliver Drugs
by Food and Drug Administration (FDA)
High tech is enabling us to get drugs to the body in unconventional ways. These methods can bring increased convenience and decreased side effects. But in a few cases, there have been unexpected problems.

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