How to use FDA in a sentence

Looking for sentences and phrases with the word FDA? Here are some examples.

Sentence Examples The FDA and other defenders of aspartame quickly debunked the report as exaggerated and baseless. Nalmefene, another opioid antagonist, is similar to naltrexone but without FDA approval for treatment of alcohol dependence. Topical antimicrobials are considered drugs by the FDA and are regulated as such. The FDA has just approved Seasonale, which provides three months of continuous contraception and menstrual suppression. Visudyne-PDT was approved by the FDA in April 2000 for the treatment of a nonmalignant disease. Then the FDA will take that into advisement and make a decision sometimes in the near future. The pressure for the FDA to act will only intensify as biotech patents expire. Specifically, FDA said the bioburden on simulated product did not represent that on the manufactured product. Find Pentothal medication description and FDA approved drug information including side effects, interactions and patient labeling. However, FDA is taking legal action against the firms that are selling illegal or unapproved products in the United States. However, the FDA is more concerned about what happens when the implants rupture. What can he say about the FDA, an agency that keeps us safe from impure food and poisonous pharmaceuticals? The drug was first approved by the FDA as a treatment for myasthenia gravis, a chronic neuromuscular disease. He defended his claims that the FDA is not protecting our health and safety. Most of the people surveyed favor FDA regulation to approve product safety. Records should be developed and maintained according to AATB recommendations that are in compliance with FDA rules. In 1993, he was successful in a suit that forced the FDA to relax its rules prohibiting drug companies from promoting off-label prescribing. Last week the FDA said antidepressant use by children actually rose this year, directly conflicting with Medco's data. Their collective brain trust will be denied to the FDA who will then have to rely on the next lower level of expertise for guidance. That one doesn't get answered as often as it should, because the FDA generally only requires testing against placebo. Show More Sentences Meanwhile, the FDA says it will tighten requirements for drug wholesalers so it's tougher to sneak counterfeits into legitimate supplies. In 1981, the FDA declared spirulina ineffective for weight loss, and no subsequent studies to the contrary have been published. Well, now they have just been approved by the FDA to be purchased over the counter so that someone can have one at home. Past bioprospected compounds that received FDA approval include taxol, topotecan, vinblastine, vincristine, and irinocetan. The spots will saturate prime-time shows and weekend sportscasts almost as soon as FDA approval is obtained. Remember that institutions must file a report with the FDA whether device malfunction or user error causes injury. Until Congress and the FDA resolve their legal squabbles, consumers are on their own. The new FDA commissioner is demonstrating an impressive decisiveness and understanding of agency bureaucracy. A review of the studies confirms that the formulation meets and exceeds the FDA definition of an antiseptic handwash. Later here, I'll be talking with woman who strongly disagrees with today's ruling by the FDA panel. Although the FDA maintains that generics are identical to their brand name counterparts, scores of readers have reported problems. Indeed, many of the assemblies have already passed reliability and quality tests needed to achieve FDA approval. The FDA will then evaluate the recommendation and either approve or disapprove the product for marketing. It is marketed under the brand name Plan B and is the second product to be labeled by the FDA for this indication. As of the report date, FDA had not determined whether the counterfeit mesh was still being marketed. But in 1998 the FDA approved thalidomide for treating the debilitating and disfiguring lesions associated with erythema nodosum leprosum. While the FDA dithers, the case against selling EC over the counter weakens by the day. The new version of the product was expected to gain at least three years marketing exclusivity from the FDA and a patent application is pending. There are currently no recombinant erythropoietic products approved by the FDA for the treatment of anemia in these patients. In its comments, Venetec noted several reasons for an FDA ban on suture securement. Show More Sentences She sought to minimize losses from its patent expiration by getting FDA approval for an additional use under another brand name. In the late 1990s the FDA silently banned Mercurochrome because of its imaginary danger to humans. Meanwhile, in January 1999, FDA rescinded its compliance policy guide that had regulated third-party servicers of medical devices. The FDA published this TFM on the testing and classification of topical antimicrobials. Finally, FDA said, the firm failed to identify the root cause of software code problems. The microwave oven in your lounge or kitchen has not been cleared by the FDA for medical use. When Congress and the FDA dreamed up the orphan drug bill they didn't consider limiting profitability. In a recent FDA Consumer Update, the agency reiterated that dental amalgams used in dental restorations are not harmful to patients. Though these uses aren't approved by the FDA, doctors can prescribe thalidomide for other indications, sometimes called off-label uses. In 1996, the NVIC realized a major goal when the FDA licensed an improved pertussis vaccine known as the acellular pertussis vaccine. The FDA ordered the ads changed within 90 days to include information about the dangers of transmitting the virus and its deadly nature. In August 2000, the FDA issued its final guidance on the practice of reprocessing and reusing medical devices intended to be used only once. The FDA has recently issued a warning that anti-depressants can cause stimulatory side-effects such as agitation, panic attacks and aggression. The FDA has been trying to get its regulatory head around the issue of biogeneric equivalency, but it isn't easy. In 1990, the FDA approved the first bioengineered enzyme, rennin, which traditionally has been extracted from calves' stomachs for use in making cheese. To the extent that the FDA has helped winnow the mainstream drug market down to scientifically proven treatments, it has been a help rather than hindrance. But when the FDA was confronted in court with evidence of such internal opposition, the agency responded by suggesting that the comments were only from low-level employees. Once Ranbaxy got FDA approval, it leaped straight into making commercial-size batches without any meaningful dry runs. The problem was that the FDA refused to approve any new ingredients for use in sunscreen, year after year. The FDA is hoping to remedy the dearth of knowledge with a plea aimed at influential drugmakers. Show More Sentences Before the FDA started cracking down, grocers might stretch your coffee with other kinds of beans, your flour with sawdust. They see the FDA decision as one more imposition on their lives and choices by the omnipresent nanny state. Every frozen or fresh package of spinach can contain up to 50 aphids, mites, or thrips before the FDA labels it contaminated. Arginox Pharmaceuticals announced that the US FDA has granted orphan drug designation to Tilarginine Acetate Injection for the treatment of cardiogenic shock. The FDA further recommended that the use of talc or lycopodium be banned, despite the fact that these substances already have been out of favor for several decades. Last year the FDA approved its use for another kind of leukemia that affects children. But with winking acquiescence, the FDA, though nominally still watching over shoulders, more or less disappeared. Environmental groups also want the FDA to require companies to disclose the use of phthalates and compounds that mimic hormones on plastic container labels. But in trying so hard to make its guidelines understandable to everyone, the FDA has made them meaningful to no one, and insulting to our intelligence to boot. In the late 1980s several generic-drug companies were caught fabricating data and bribing FDA officials to gain approval. The sales rep said he gave Harris screws to take back to the FDA district office in Ontario, California. This was in spite of such FDA victories as the ban of thalidomide, which caused phocomelia in more than 8000 babies in Europe, where the drug was freely used. While the FDA shares concerns about safety, some insiders argue that scientific advancements have made it easier to characterize and replicate biologics. A couple of examples from my own experience at FDA with the review of biopharmaceuticals will illustrate the tension between the regulatory culture and innovation. Since the FDA approved Plan B in 1999, repeated studies have shown the drug does not inhibit implantation. From there, they are then sent to an FDA lab for confirmatory chemical testing. This week, an FDA committee recommended modifying the ban, but essentially still keeping it in place. But the FDA allowed Spinal Solutions to continue selling its products while the company tried to shape up, court filings show. The FDA said anyplace where 50 percent of square footage was devoted to preparing and serving food. Inaccurate label notwithstanding, Plan B is classified by the FDA as a contraceptive. Show More Sentences The FDA is now apparently taking policy cues from The End, a 1978 comedy starring Burt Reynolds and dom DeLuise. The FDA insists generic drugs are just like their brand-name counterparts. The FDA also has approved use of a new rapid oral HIV test kit, which provides results within 20 minutes using material collected from an oral swab. However, apart from the poultry, which is of the lowest FDA grade, soy protein plays a role in everything served. The FDA website contained information that differed from both versions of the PDF guide. Many experts now say the FDA labels for plan B and similar morning-after pills are not current with the most recent research. The saga of juice tainted by a fungicide in Brazil reveals holes in the FDA screening process for imported foods. In regard to reproductive cloning, Guenin maintains that because the FDA has effectively interdicted the practice, the likely incidence in the U.S. is nil. The FDA labels the practice unsafe, unsound, and ill-considered. The FDA has ruled that electronic cigarettes, cigars, and similar devices contain known carcinogens and slammed them for being marketed to younger age groups. The FDA has had a run-in with Allergan before, condemning it for advertisements that it said suggested the drug was effective for unapproved uses. In FDA sanctioned studies using MDMA-assisted therapy to treat veterans with PTSD, the success rate has been astounding. As a complement to the board's oversight, FDA will improve transparency by sharing drug safety information sooner and more broadly and conveniently. The FDA pulled phenformin off the shelves in the 1970s because it had toxic side effects. In 1997, CSPI petitioned the FDA to set rules for egg producers that would prevent contamination of their eggs with Salmonella bacteria. Congressional investigations into whether the FDA is truly living up to its responsibilities would help, but they're unlikely any time soon. The RFD enables the FDA to determine the product type and appropriate lead center. The FDA found no treatment advantage in using Rebif compared to the other interferons. It is NOT natural calcium fluoride, and the FDA has NEVER approved any synthetic fluorides for human ingestion. Pegsiticase has received Orphan Drug designation from the FDA for refractory gout, tumor lysis syndrome and Lesch-Nyhan Syndrome. Show More Sentences An expanded access protocol allows patients to benefit from an investigational drug prior to FDA approval. If the Academy decides that preemies do need linolenic acid or DHA, the FDA will then ask it about full-term babies. The treatment of gallstone with our existing lithotripters was approved by the FDA in September. The FDA today ordered the withdrawal of four tobacco products that it found were not substantially equivalent to existing products. However, it is not currently The vaccine that the FDA recommends is an oral attenuated live vaccine that is effective as a single dose. The FDA is planning to release a draft guidance on follow-on biologics this spring. A rotary lobe pump, the BLK Hy-clean is compliant with EHEDG, FDA and 3A regulations. The FDA has placed farmed catfish from China on a watch list for illegal residues of malachite green and fluoroquinolones. On June 6, the FDA banned 15 food products from Taiwan that were found to contain maleic acid. So, as the FDA celebrates its centenary, are our bratwursts any less likely to contain cow eyeballs than in Upton Sinclair's day? The FDA has put at stake the accountability and credibility of state legislatures in this precedent setting rule making. In October 2008, the FDA issued new rules governing the analysis of melamine and cyanuric acid in infant formulations. Antistatic Industries has introduced a new, static dissipative, FDA compliant floor and wall paint. There is no approved generic formulation of Tamiflu, the FDA said in a statement. Rockwell is preparing to launch its FDA approved generic drug called Calcitriol to treat secondary hyperparathyroidism in dialysis patients. Fablyn, or lasofoxifene tartrate, was rejected by the FDA in September 2005 as a medicine to prevent osteoporosis. To prevent future confusion, the FDA has revised the labeling to show the sum of the two active ingredients, ceftolozane and tazobactam. Resolute Oil maintains Kosher certification on the facility related to all activity on FDA and white mineral oils. OraDisc A is an improved delivery system for amlexanox, which has previously been approved by the FDA for the treatment of canker sores. The FDA has determined that the levels of ECH residues in carrageen do not represent a safety concern. Show More Sentences The procedure, also referred to as emergency contraception, is different from the abortion pill RU-486, which the FDA has not approved. It is a synthetic thebaine derivative that was approved by the FDA in 2002 for the treatment of opioid dependence. It is said to provide better nucleation than sodium benzoate and is expected to be approved by FDA in the near future. Prescription-only barrier methods in the FDA guide include the diaphragm and the cervical cap, both used with spermicide. They claim FDA did not have proper resources to inspect imported catfish. The only FDA approved treatment alternatives for opiate detoxification today are drugs that have their own addictive properties. The FDA recently approved a new treatment for head lice, spinosad for use on children age four and older. Phloxine B and Eosin Yellow are halogenated photoactive xanthene dyes, that are FDA approved for use in human cosmetics and drugs. The filing of an NDA with the FDA is an important step in the approval process in the United States. InSite Vision has submitted an electronic NDA filing in a modified Common Technical Document format to the FDA for regulatory review. With FDA clearance, the Scanmaster DX is now available for sale in the teleradiology market as well as for clinical diagnosis. Andrew von Eschenbach, FDA Acting Commissioner, along with numerous other FDA and CMS officials. The US FDA and ANMAT also approved the product for the treatment of refractory and recurring external condylomata acuminate. No other product is approved by the FDA to prevent anthrax before exposure. The FDA also reclassified sunlamp products and ultraviolet lamps from low risk to moderate risk. Currently, the FDA classifies tanning sunlamps as class I medical devices 6 a category shared by products like bandages and tongue depressors. The FDA does not have to approve or review cosmetics, or what goes in them, before they are sold to the consumers. The FDA has recently approved a new treatment for chronic plantar fasciitis that hasn't responded to conservative treatment. Finger alerted the FDA because he had a similar yet milder reaction after eating the white corn chips he purchased. However, representatives of the nutraceutical industry say they plan to call for amendments to the proposed FDA rules. Show More Sentences The FDA only regulates against some colors that can be used in the cosmetics and hair dyes. This decision was announced November 1, 2004 after application to the FDA by producers. The efficacy of Organogenesis products has been established through rigorous premarket approval studies required for FDA approval. However, the FDA review process may be speedier for Orphan Drugs than those which do not receive Orphan Drug designation. As a result of the Weiss hearing, the FDA conducted an extensive investigation into the adverse-reaction reporting practices of McNeil and Ortho. The FDA and European Medicines Agency have both previously granted Bronchitol orphan drug status for treating cystic fibrosis. The FDA approves the viral load test, a new diagnostic test that measures the level of HIV in the blood. Oxybenzone is an FDA approved over-the-counter sunscreen active ingredient. Currently pending FDA approval, EndoFLIP provides a more physiologically relevant diagnostic test for gastroesophageal reflux disease. The FDA has finally recognised laser therapy as a treatment for regrowing hair. The FDA now believes not enough evidence indicates clove oil or eugenol is effective for toothache pain or a variety of other types of pain. In these infrequent instances, sterilization may be accomplished by immersion in liquid chemical germicides registered by FDA as sterilants. To be approved, the FDA monograph on fluoride dentifrices requires that enamel solubility and fluoride uptake be demonstrated in vitro. Entecavir, an oral drug of oral deoxyguanosine, was developed by Bristol-Myers Squibb and approved to enter the market by FDA in Mar. In July 2014 several vials of smallpox were discovered in an FDA laboratory at the National Institutes of Health location in Bethesda, Maryland. To approve TEA ingredients, the FDA recently signaled that these ingredients have to conform to GRASE requirements. Reticulose is presently available through a compassionate use program approved by the FDA, but many activists are claiming this is not enough. In February, the franchise received FDA approval for its Reclaim Revision Femoral Hip System and Gription TF titanium foam implants. The advent of the new, FDA cleared cohesive silicone gel breast implants makes the risks of visible ripples lower compared to saline implants. In 1991, I received a CI soon after the FDA approved it for pediatric use. Show More Sentences The authors of this working paper argue that reform should hearken back to the original FDA rule. Common adverse reactions to polidocanol include pain or hematoma at the injection site, bruising, irritation, and discoloration, the FDA said. Covidien in April 2014 received FDA approval for Emprint Ablation System with Thermosphere Technology for liver tumor ablation. The Company has also received FDA approval for its En Garde, needlescopic product used for a percutaneous approach to prosthetic fixation. The FDA recommends that estrogens and progestins should be used at the lowest doses for the shortest duration needed to achieve treatment goals. This risk is of particular concern because the FDA would like to see some evidence of dose response from a proof of concept study. The FDA is now actively seeking out doctors and manufacturers who make excimer lasers without the agency's permission. A version of the Chocolate platform, Chocolate PTCA, is also approved by FDA to treat patients' coronary arteries. In January 2013, the FDA recommended reducing the dose for sleep medications containing zolpidem, which include Ambien and Ambien, for the same reason. This includes a section on Alternative Medicine Fraud, such as a warning that Ayurvedic products generally have not been approved by the FDA before marketing. The ingredients, generally recognized as safe by the FDA, include bitter gourd, naja jihwa, jambul, fenugreek, bengal quince, gurmar and cinnamon. This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. A new user fee may be assessed if FDA conducts a reinspection to evaluate corrective actions that were classified Official Action Indicated and determined to be material. Rene Charles, a gynecologic laparoscopist at Selma Community Hospital, presented the results of the LapCap clinical trial which supported FDA clearance of the device. Data in the company's submission for Lovan were based on six-month efficacy studies, which were the criteria the FDA had in place at the time of the filing. In announcing its approval of Vyvanse, the FDA cited outcomes from two clinical studies involving 724 adults with moderate to severe binge eating disorders. The company plans to file an investigational new drug application with the FDA for this program, which has been demonstrated to rescue vision in blind rats. Broken breast implants have mutilated many tens of thousands of women specifically because the review process at the FDA better accommodates industry than patient health. Ongoing FDA laboratory analyses of Reumofan Plus found it to contain the prescription drug ingredients dexamethasone, diclofenac sodium and methocarbamol. Show More Sentences ThyroTest, an FDA regulated and CLIA-waived rapid immunoassay test, was developed for in-office thyroid diagnosing using a single drop of blood on a small test card. In 1998, FDA began to require certain TMJ implant manufacturers sponsoring these devices to demonstrate the implants' safety and effectiveness before receiving approval. Mylan also received final FDA approval for its ANDA for Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, the generic version of Merck's Singulair Chewable Tablets. The FDA recently announced a Class II recall for Zimmer's Persona Trabecular Metal Tibial Plate knee implant, affecting all lots and sizes of the knee implant. The FDA has issued a final order reclassifying sunlamp products and ultraviolet lamps intended for use in sunlamp products from low-risk to moderate-risk devices. The 1998 Consent Decree provided that if Mentor maintained a state of continuous compliance with the Decree for five years, the FDA would not oppose dissolving the Decree. It's the world's one and only treatment that''s FDA proven to lift the face and neck nonsurgically, treating from the bone up, tightening all those tissues. The FDA is warning clinicians not to use certain intravenous bags of metronidazole, ciprofloxacin, and ondansetron due to potential contamination. There is one urethral bulking agent currently approved by the FDA for treatment of a subclass of SUI in which the urethral sphincter is unable to close. The FDA claims that URPs are created in such small quantities and are so similar to other safe byproducts that they should be considered harmless. In late 1990, the FDA asked the Justice Department to investigate whether Ortho had engaged in an illegal promotion of Retin-A for an unapproved use. Cubist has a unique understanding of daptomycin and is sharing this understanding with the FDA, via the Citizen Petition, in the interest of public health. In their approval letter, the FDA noted there are limited treatment options for diabetic gastroparesis and agents currently available have serious side effects. To help develop the guidance and learn how to address microarray data, the FDA Office of Testing and Research has launched two gene expression database projects. Products targeted in CSPI's complaints to FDA include GinkgOs brand cereal, whose makers say the product enhances mental alertness, as does Arizona's Memory Elixir. Accordingly, the FDA recommended that an additional trial involving only patients with typical venous ulcers be conducted to confirm Ortec's findings. The drug was reformulated in 1976 to remove an ingredient called dicyclomine hydrochloride, which the FDA found did not contribute to the drug's overall effectiveness. Nascobal is Nastech's FDA approved therapy for the treatment of vitamin B12 deficient patients with Crohn's disease, Colitis, pernicious anemia, and certain other conditions. Upcoming moves by the FDA could spur a number of pharmacogenomic studies for warfarin and eventually bring pharmacogenomic tests into the mainstream. The combination of DTIC with YERVOY is not an FDA approved-regimen. Show More Sentences Thus, although the FDA can talk tough and clamp down on the electronic cigarette, it is barred by Congress from removing the real killer from the market. Gottlieb refused to address those charges, but defended FDA policy that allows the agency leeway in impaneling advisory committee members who have financial ties to industry. In July, the FDA approved Allegra, known generically as fexofenadine. In 1996, after 52 reports of tendon injury, the consumer advocacy group Public Citizen petitioned the FDA for a class warning on all fluoroquinolone antibiotics. The FDA also notified GSK that it did not approve a second indication, for the treatment of secondarily-infected dermatoses, in the same New Drug Application. The FDA has approved Tykerb, in combination with Xeloda, for the treatment of women with advanced HER2-positive breast cancer who have received prior therapy. Examples from Classical Literature Philip Augustus afterwards caused much more complete registers of the FDA Normannorum to be formed. The MRcYeescope, a single-piece, entirely disposable laryngoscope, has been cleared by the FDA for use in the MR environment. We intend to work closely with the FDA to elucidate these findings and determine the next steps for NBI-77860 in congenital adrenal hyperplasia. It is not merely the use of exotic, experimental new drugs that the FDA stymies. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said. At this point, it's unclear whether FDA approval would factor both the pharmacist and the doctor out of the purchase. I am hopeful FDA will negotiate, compromise and come back with a guidance that is attainable, appropriate and embraceable by industry. The product, commercialized as the Provant Wound Closure System, has FDA clearance as a wound treatment device. Another significant milestone worth noting is that the FDA granted Nascent Biotech an Orphan Drug Designation for Gliomas. Nutrition 21, LLC, has launched Nitrosigine, a novel patented source of inositol-stabilized arginine silicate accepted by FDA as a New Dietary Ingredient. The FDA shares that long-term care facilities report the majority of entrapments and the number of tragic adverse events likely is higher because many cases go unreported. The pink lemonade example in the FDA policy is a good illustration. Tables of information accompany color charts of drug indicators, FDA guideline updates, and more, making this pocket edition invaluable to any clinician. Second, the trigger concentrations of pharmaceuticals that prompt risk assessment under the FDA and EMEA guidance differ by a factor of 10 when dilution is taken into account. Find more words! 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