* Approved Drug Products with Therapeutic Equivalence Evaluations, published by the FDA's Center for Drug Evaluation and Research

The Center for Reproductive Rights then filed a lawsuit, and deposed Dr John Jenkins, director of the FDA's Office of New Drugs.

His father, Herman Benjamin Segal, is a cardiologist originally from Portland, Maine, and his mother, Andrea Leonard-Segal, is a rheumatologist working for the FDA's Center for Drug Evaluation and Research.

The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration.

According to the FDA's statement on the subject, " These unapproved products have put consumers ' health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products ," said Janet Woodcock, M. D., director for the Center for Drug Evaluation and Research.

The FDA's federal budget request for fiscal year ( FY ) 2012 totaled $ 4. 36 billion.

The FDA's federal budget request for fiscal year ( FY ) 2008 ( October 2007 through September 2008 ) totaled $ 2. 1 billion, a $ 105. 8 million increase from what it received for fiscal year 2007.

This is reflected in the recent decision by the FDA's Neurological Devices Advisory Panel to maintain ECT devices in the Class III device category for high risk devices except for patients suffering from catatonia.

In 2008, the drug was put on the FDA's Potential Signals of Serious Risks List to be further evaluated for approval.

The FDA's February 2004 announcement of approval for use of Erbitux for treatment of colorectal cancer reported that conclusions were drawn from a trial involving 329 patients, of which 10. 8 % responded when Erbitux was used by itself, delaying tumor growth by 1. 5 months.

FDA's permitted colors are classified as subject to certification or exempt from certification, both of which are subject to rigorous safety standards prior to their approval and listing for use in foods.

The FDA appealed this ruling, and on August 17, 2006 the U. S. Court of Appeals for the Tenth Circuit upheld the FDA's ban of ephedra.

Lobelia has been used to treat respiratory diseases like asthma and bronchitis, and has been used for smoking cessation because of chemical similarities to tobacco ; lobelia is now listed in the FDA's Poisonous Plant Database.

The FDA's approval of Viagra ( Sildenafil ) on March 27, 1998 was a ground-breaking commercial event for the treatment of ED, with sales exceeding one billion dollars.

During the FDA's December 13 – 14, 2010 CDHR panel review of the International Academy of Oral Medicine and Toxicology's request for reconsideration to the classification of amalgam, neurologists questioned the type of neurobehavorial tests and the unethical nature of a prospective trial looking for brain damage in children.

Despite the FDA's issuing an approvable letter in February 2006 for the obesity indication, and a nonapprovable letter for smoking cessation, the drug did not enter the market in the United States in 2006.

On 13 June 2007, FDA's Endocrine and Metabolic Drugs Advisory Committee ( EMDAC ) concluded the French manufacturer Sanofi-Aventis failed to demonstrate the safety of rimonabant and voted against recommending the anti-obesity treatment for approval.

In July 2010, after new studies failed to show a significant benefit, the FDA's advisory panel recommended against the indication for advanced breast cancer.

In 1998, the first year olestra products were marketed nationally after the FDA's Food Advisory Committee confirmed a judgment it made two years earlier, sales were over $ 400 million.

For example, the following is an excerpt from the Federal Register: " The Food and Drug Administration ( FDA ) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter ( OTC ) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing

* FDA's online database of " Everything " Added to Food in the United States ( EAFUS ): A Food Additive Database

The FDA's authority to regulate came from the Food, Drug, and Cosmetic Act ( FDCA ).

According to the FDA's New Safety Information Identified by the Adverse Event Reporting System ( AERS ) Phenytoin Injection ( Dilantin ) has been associated with the risk of Purple Glove Syndrome.

* Predictive Safety Testing Consortium aiming to identify and clinically qualify safety biomarkers for regulatory use as part of the FDA's Critical Path Initiative

* In February 2006, the FDA's Drug Safety and Risk Management Advisory Committee voted to include boxed warnings on methylphenidate formulations used to treat attention deficit hyperactivity disorder, such as Ritalin ( methylphenidate ), due to possible cardiovascular side-effects.

Says Wallace F. Jannsen, director of the FDA's Division of Public Information: `` Quacks are apt to direct their appeal directly to older people, or to sufferers from chronic ailments such as arthritis, rheumatism, diabetes, and cancer.

It noted that under the FDA's 2006 guidance on lead in candy, only 0. 2 micrograms of lead per serving are allowed.

Statistics of sentinel events are recorded and published by the FDA's MedWatch program.

Regardless of the name chosen, the IRB is subject to the FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved.

Similar arguments are noted for the FDA's regulation on stevia now labeled as a " dietary supplement " instead of a " sweetener ".

The Office of Regulatory Affairs is considered the " eyes and ears " of the agency, conducting the vast majority of the FDA's work in the field.

The FDA's stated reason was " toxicological information on stevia is inadequate to demonstrate its safety.

Despite opium tincture being an " unapproved drug " as discussed above, a search of FDA's website does not reveal any efforts at this time to ban opium tincture or restrict its use ; in fact, the FDA has a web page devoted to patient and practitioner education about opium tincture.

" This warning may indicate a shift in FDA policy toward banning opium tincture or at least requiring the product to be brought within the FDA's regulatory framework.

Despite the FDA's efforts over the past few years, the confusion persists, sometimes with deadly results.

While Canada does not federally regulate freezing fish, British Columbia and Alberta voluntarily adhere to guidelines similar to the FDA's.

Ginger is on the FDA's " generally recognized as safe " list, though it does interact with some medications, including warfarin.

Waksal got wind of the FDA's rejection on Christmas Day 2001.

According to Consumer Reports, " The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications " and it became the FDA's responsibility to prove that a supplement is not safe.

In September 2007 the company announced that it was making preparations for another phase III clinical trial ( intended to be named STRIDE-5 ) to overcome the FDA's concerns ..

Going back over this ground and analyzing the composition of forces which have created the present scene is one of the tasks undertaken by the Center for the Study of Democratic Institutions, in Santa Barbara.

All nine members of the Inter-American Center Authority voted for Goodbody & Company's proposal to finance the long-awaited trade and cultural center.

After being located for some years in the Village at the Equinox Pharmacy under the supervision of Mrs. Harry Mercier, it is presently located in the Hill and Dale Shop, Manchester Center.

This was the chief reason for a so-so sales outlook given by two-thirds of 56 builders polled by the National Housing Center.

The silver and ebony plaques will be presented at noon luncheons by Stanley Marcus, president of Neiman-Marcus, Beneficiary of the proceeds from the two showings will be the Dallas Society for Crippled Children Cerebral Palsy Treatment Center.

The existing reverence for Centrality must have been still further stimulated toward the close of the second century B.C., when the Han Emperor Wu Ti ordered the dynastic color changed to yellow -- which symbolized the Center among the traditional Five Directions -- and took 5 as the dynastic number, believing that he would thus place himself, his imperial family, and the nation under the most auspicious influences.

We find, for example, such groupings as the Five Ancient Rulers, the Five Sacred Mountains, the Five Directions ( with Center ), the Five Metals, Five Colors, Five Tastes, Five Odors, Five Musical Notes, Five Bodily Functions, Five Viscera, and many others.

This season the orchestra has already taken a step toward the suburbs in that it is giving six subscription concerts for the Orchestral Society of Westchester in the County Center in White Plains.

Presentation of `` The Life And Times Of John Sloan '' in the Delaware Art Center here suggests a current nostalgia for human values in art.

Several organizations, such as the American Association of Variable Star Observers and Center for Backyard Astrophysics, exist to help coordinate these contributions.

In 1969, the institute established the Center for Advanced Film Studies at Greystone, the Doheny Mansion in Beverly Hills, CA.

* Markkula Center for Applied Ethics at Santa Clara University

In Mexico, exiled Republican intellectuals extended the Annales approach, particularly from the Center for Historical Studies of El Colegio de México, the leading graduate studies institution of Latin America.

The replica ABC is now on permanent display in the first floor lobby of the Durham Center for Computation and Communication at Iowa State University.

The program laid the foundation for NASA's current human spaceflight capability, and funded construction of its Johnson Space Center and Kennedy Space Center.

But an even bigger facility would be needed for the mammoth rocket required for the manned lunar mission, so land acquisition was started in July 1961 for a Launch Operations Center ( LOC ) immediately north of Canaveral at Merritt Island.

Ayurveda, Chinese medicine, Homeopathy and Naturopathy are cited as examples The term appears to have entered into usage through the National Institute of Health's National Center for Complementary and Alternative Medicine ( NCCAM ), which began to employ it as a substitute for alternative medical systems as a way of differentiating widely comprehensive systems of medicine, such as Ayurvedic medicine, from specialized alternative approaches.

Located on the 3rd floor of the Memorial Union, the Sun Devil Involvement Center ( SDIC ) provides opportunities for student involvement through clubs, sororities, fraternities, community service, leadership, student government, and co-curricular programming.

In July 2011, after returning the piece of debris at NASA's request, the sixteen-year-old Schanze was given an all-access tour of the Kennedy Space Center as well as VIP seating for the launch of STS-135, the final mission of the Space Shuttle program.

Austin is also home to numerous child developmental institutions including the Center for Autism and Related Disorders, the Central Texas Autism Center, Autism Early Learning Center, Johnson Center for Child Health and Development and many more.