Ampicillin has received FDA approval for its mechanism of action.

In the U. S., the FDA has banned import of any donor sperm, motivated by a risk of Creutzfeldt – Jakob disease, inhibiting the once popular import of, for example, Scandinavian sperm.

The US FDA has approved two Chagas tests, including one approved in April 2010, and has published guidelines that recommend testing of all donated blood and tissue products.

( Pine tar has historically also been used for this purpose, but has been banned as a medical product by the FDA, since no evidence was submitted proving it is effective.

Estimated dietary intake has also declined, although FDA food tests commonly detect it.

The U. S. Food and Drug Administration ( FDA ), with support from the TSE ( Transmissible spongiform encephalopathy ) Advisory Committee, has since 1997 been monitoring the potential risk of transmitting animal diseases, especially bovine spongiform encephalopathy ( BSE ), commonly known as Mad Cow disease.

In consequence, the United States Department of Agriculture ( USDA ) has approved the use of low-level irradiation as an alternative treatment to pesticides for fruits and vegetables that are considered hosts to a number of insect pests, including fruit flies and seed weevils ; the U. S. Food and Drug Administration ( FDA ) has cleared among a number of other applications the treatment of hamburger patties to eliminate the residual risk of a contamination by a virulent E. coli.

However, the U. S. Food and Drug Administration ( FDA ) has not formally evaluated the effectiveness of these products.

In the case of cochlear implants, the US FDA has approved some implants for MRI compatibility.

" The advisory went on to say that " the FDA has received reports of death and life-threatening side effects in patients taking methadone.

After extensive clinical trials, Kuvan has been approved by the FDA for use in PKU therapy.

At the Federal level, consistent with Section 341 of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration ( FDA ) has defined standards of identity for what are broadly termed macaroni and noodle products.

The adverse drug reaction profile of ciprofloxacin and other fluoroquinolone drugs has spawned a grass-roots movement of those so affected to lobby for black box warnings and Dear Doctor letters, as well as the petitioning of the FDA for the removal of some fluoroquinolone drugs from clinical practice.

In 2011, the FDA has added another boxed warning that says fluoroquinolones, due to their neuromuscular blocking activity, may exacerbate muscle weakness in persons with myasthenia gravis.

Quinine was also frequently prescribed in the US as an " off-label " treatment for nocturnal leg cramps, but this has since been prohibited, in effect, by an FDA statement warning against the practice.

Doctors may still prescribe quinine, but the FDA has ordered firms to stop marketing unapproved drug products containing quinine.

Though Legatrin was banned by the FDA for the treatment of leg cramps, drug manufacturer URL Mutual has branded a quinine-containing drug named Qualaquin.

The FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements.

A soft drink ( also called soda, pop, coke, soda pop, fizzy drink, tonic, seltzer, mineral, has uncovered additional FDA test results that showed the following results: Of 24 samples of diet soda tested between 1995 and 2001 for the presence of benzene, 19 ( 79 %) had amounts of benzene in excess of the federal tap water standard of 5 ppb.

# Medical software: The U. S. Food and Drug Administration ( FDA ) has identified the use of static analysis for medical devices.

The US FDA has not approved any form of vitamin K for the prevention or treatment of osteoporosis ; however, MK4 has been shown to decrease fractures up to 87 %.

Emergent BioSolutions is developing an array of biodefense and commercial products and currently manufactures the only FDA approved anthrax vaccine at its Lansing operations.

The FDA recommends that this substance be identified by a name other than " placental extract " and describing its composition more accurately because consumers associate the name " placental extract " with a therapeutic use of some biological activity.

Despite these findings, as of 2006, the FDA stated its belief that " the levels of benzene found in soft drinks and other beverages to date do not pose a safety concern for consumers ".

" To protect the complainant, the FDA deleted names in the original complaint in its responses to requests filed under the Freedom of Information Act.

Stevia remained banned until after the 1994 Dietary Supplement Health and Education Act forced the FDA in 1995 to revise its stance to permit stevia to be used as a dietary supplement, although not as a food additive – a position that stevia proponents regarded as contradictory because it simultaneously labels stevia as safe and unsafe, depending on how it is sold.

* United States, Disney: In February 2004, Disney banned Segway PTs from its theme parks, stating they had not been approved by the FDA as medical devices.

Sonography is used routinely in obstetric appointments during pregnancy, but the FDA discourages its use for non-medical purposes such as fetal keepsake videos and photos, even though it is the same technology used in hospitals.

Given its " grandfathered " status, opium tincture has never been required to undergo the strict FDA drug review and approval process.

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.

Modern uses of thalidomide ( trademarked as Thalomid, according to FDA Orange Book ) include treating multiple myeloma in combination with dexamethasone, and erythema nodosum leprosum, with strict controls on its use to prevent birth defects.

The FDA approval came seven years after the first reports of efficacy in the medical literature and Celgene took advantage of " off-label " marketing opportunities to promote the drug in advance of its FDA approval for the myeloma indication.

The FDA formed a Thalidomide Working Group in 1994 to provide consistency between its divisions, with particular emphasis on safety monitoring.

Catha edulis ( khat ) is a stimulant narcotic that is similar to that of amphetamine and its congeners, not a drug as categorized by U. S. FDA ( United States Food & Drug Administration ) and FDA import Alert # 66-23 ( published date 03 / 18 / 2011 ) states that " Districts may detain, without physical examination, all entries of khat ", based on section 801 ( a ) ( 3 ) of the Federal Food, Drug, and Cosmetic Act on the grounds that " its labeling fails to bear adequate directions for use ".

To date, the FDA has not been presented with scientific information that would support a change in conclusions about the safety of these approved high-intensity sweeteners ( with the exception of Stevia, which is exempt under FDA's GRAS policy due to its being a natural substance in wide use well before 1958, and has been approved by FDA ).

The resulting conglomerate took the name of " Pharmacia Corp ." Monsanto, via its Searle division, had developed celecoxib which became a blockbuster drug soon after its approval by the FDA at the end of 1998.

*; Mercurochrome: Not recognized as safe and effective by the U. S. Food and Drug Administration ( FDA ) due to concerns about its mercury content.

ImClone's stock price dropped sharply at the end of 2001 when its drug Erbitux, an experimental monoclonal antibody, failed to get the expected Food and Drug Administration ( FDA ) approval.

It adjoins the headquarters of the American Physical Society and the Food and Drug Administration ( FDA ).

FDA approval usually requires that 50 % of the patient treatment group had at least a 50 % improvement in the rate of epileptic seizures.

When the FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak.

The FDA study concluded: "... steps such as heat, alkaline treatment, and filtration could be effective in reducing the level of contaminating TSE agents ; however, scientific evidence is insufficient at this time to demonstrate that these treatments would effectively remove the BSE infectious agent if present in the source material.

FDA is currently proposing a rule that in some cases would allow certain irradiated foods to be marketed without any labeling at all.

According to an Environmental Working Group analysis of USDA and FDA pesticide residue tests performed from 2000 through 2008, 84 % of the 2, 216 tested potato samples contained detectable traces of at least one pesticide.

Following the FDA ’ s standards, a number of states have, at various times, enacted their own statutes that serve as mandates for various forms of macaroni and noodle products that may be produced or sold within their borders.

On November 8, 2007, additional " black box " warnings were included on the aranesp label, at the request of the FDA.

" 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.

The U. S. Food and Drug Administration ( FDA ) recommends freezing at − 35 ° C (− 31 ° F ) for 15 hours, or at − 20 ° C (− 4 ° F ) for 7 days.

However, the Court denied such review in the second companion case because any harm from noncompliance with the FDA regulation at issue was too speculative in the Court's opinion to justify judicial review.

The award, given annually to an FDA staff member, came 50 years after Kelsey, then a new medical officer at the agency, first reviewed the application from the William S. Merrell Company of Cincinnati.

Current supplemental guidelines recommend doses of phytosterols in the 1. 6-3. 0 grams per day range ( Health Canada, EFSA, ATP III, FDA ) with a recent meta-analysis demonstrating an 8. 8 % reduction in LDL-cholesterol at a mean dose of 2. 15 gram per day.

* 1999 — Researchers at the Institute for Human Gene Therapy at the University of Pennsylvania accidentally kill Jesse Gelsinger during a clinical trial of a gene therapy technique, leading the FDA to halt further gene therapy trials at the Institute.

In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the FDA, and agreed to a $ 2. 3 billion settlement, the largest health care fraud settlement at that time.

On Wednesday, May 5, 2010, the Food and Drug Administration ( FDA ) confirmed that the bacteria found at the Johnson & Johnson plant that made the recalled Children's Tylenol was Burkholderia cepacia, a bacteria often resistant to common antibiotics.

It states, " The FDA literature he comes in contact with is not to be read by him at all.

The two companies settled out of court, and it was announced that Oakhurst would add the word " used " at the end of its label, and note that the US FDA claims there is no major difference between milk from rBST-treated and non rBST-treated cows.