Sentences with phrase «by drug manufacturers»

Prescription drugs that are no longer patent - protected and are sold by drug manufacturers under a different name than the original brand name drug.

The FDA does not conduct tests on new drugs itself, but reviews the clinical trial data provided by drug manufacturers.

Some one in the last thread brought up the practice by drug manufacturers of packaging drugs with happy smiley faced people on them and listing the possible serious side effects somewhere on the side or in the box in a pamphlet.

What sense do you have of the support by drug manufacturers for this type of modeling?

-- Opioid epidemic surcharge ($ 127 million): With New York among the states hit hardest by the heroin and painkiller addiction epidemic, Cuomo is looking to place a 2 - cents - per - milligram tax on opioids sold in the state, to be paid by drug manufacturers.

The BC1 02 study additionally cited by the drug manufacturer was not considered because radium - 223 was not used in compliance with its approval in this study.

All 16 groups were reflected in the dossier compiled by the drug manufacturer, but the data were informative for only 3 of these groups.

All ten groups were reflected in the dossier compiled by the drug manufacturer, but the data were informative for only three of these groups.

Compounding is generally regulated by individual states with varying levels of oversight; however, there is one commercially available form of potassium bromide (K - BroVet) that is prepared by a drug manufacturer licensed by the FDA and which adheres to FDA manufacturing standards.

Lawsuits filed by patients who took the antipsychotic medication, Risperdal, now number in the thousands, worth potentially billions of dollars in settlements to be paid by drug manufacturer, Johnson and Johnson.

The Divisional Court dismissed the application for judicial review brought by another drug manufacturer, finding that the drug approvals process was transparent, even - handed, fair and reasonable.

Not exact matches

«What this shows is that increased competition among manufacturers, the aggressive negotiations by pharmacy benefits managers, and to some extent the significant public discussion about drug pricing and prices have all contributed to a relatively modest level of growth in 2015,» says Murray Aitken, Executive Director of the IMS Institute.

In 2008, Express Scripts paid $ 9.3 million to settle a suit by New York and 28 other states that claimed it deceptively inflated costs for state employees, in part by secretly switching to higher - cost drugs, and that it allegedly pocketed millions in manufacturer rebates.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Taking dangerous quantities of the otherwise safe loperamide is one strategy being used by people addicted to opioid painkillers and other drugs since it can increase opioid absorption in the gut; the FDA says it is now working with loperamide manufacturers to change its packaging so that it comes with fewer doses and is thus harder to abuse.

The Food and Drug Administration (FDA) is working with manufacturers to tweak the packaging of loperamide, a common OTC and prescription anti-diarrhea medication that is now also being used by people addicted to opioids to stem withdrawal symptoms or enhance their highs.

According to the GAO report, 71 percent of all generic injectable cancer drugs sold in 2008 were produced by just three manufacturers, while 91 percent of the market share of injectable nutrients and supplements was held by just three pharmaceutical firms.

«The manufacturer of a drug has no influence or control over the prices charged by a secondary wholesaler to a hospital or pharmacy,» reads part of a statement on the PhRMA web site, the industry's trade association group.

By adding a health insurance company in the form of Aetna, the resulting combination — retailer, clinic operator, pharmacy benefits manager, and insurer — can realize significant efficiencies, negotiate for lower drug prices with pharmaceutical manufacturers, and capture the growing share of healthcare spend among consumers and employers.

By acquiring Humana, Walmart gains preferential access to seniors through Humana Medicare advantage, and leverage over pharmaceutical manufacturers to negotiate for lower drug prices.

House Democrats have started what they called an «in - depth» investigation into the pricing of drugs for neurological condition multiple sclerosis, the latest attempt by U.S. politicians to pressure manufacturers to lower costs.

As an investment, a drug that is in the discovery or pre-clinical stage is a very risky proposition, with less than a 1 % chance of getting to market (according to an industry report published in 2003 by the Pharmaceutical Research and Manufacturers of America).

In March, Attorney General Jeff Sessions said the federal government would support a series of lawsuits filed by states against drug manufacturers.

Investing in Eagle Product Inspection equipment can help manufacturers comply with Good Manufacturing Practice, in particular 21 CFR Parts 210 and 211, GAMP ¬ ¬ - 4 and 21 CFR Part 11, which are enforced by the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMEA) in Europe.

(Washington, D.C.) The Grocery Manufacturers Association (GMA) issued the following statement by Dr. Leon Bruner, GMA's chief science officer, regarding the decision by the U.S. Food & Drug Administration (FDA) to accept for review industry's food additive petition seeking approval for a specified set of low - level uses of partially hydrogenated oil (PHOs) in food products.

Statement by the Grocery Manufacturers Association (GMA) President and CEO, Pamela G. Bailey, Regarding the U.S. Food & Drug Administration's (FDA) Release of Proposed Food Safety Regulations

Disgruntled US chocolate manufacturer Guittard is mounting a defence of chocolate ahead of possible changes to the product's composition by the US Food and Drug Administration (FDA).

The Grocery Manufacturers Association issued the following statement by Leon Bruner, Chief Science Officer, on the draft sodium reduction guidelines and food category targets released today by the U.S. Food and Drug Administration (FDA).

In a long - awaited step toward accurate gluten - free food labeling, the Food and Drug Administration (FDA) has released its definition of «gluten free» to be used by food manufacturers.

The Grocery Manufacturers Association today issued the following statement by Pamela G. Bailey, president and CEO, on the announcement that President - elect Trump intends to nominate Scott Gottlieb as Commissioner of the Food and Drug Administration.

(Washington, D.C.) The Grocery Manufacturers Association (GMA) issued the following statement from Dr. Leon Bruner, GMA's chief science officer, on the release today of a newNutrition Facts panel by the U.S. Food and Drug Administration (FDA):

Other «Undisclosed Ingredients» — Because protein powders, like other supplements, are not regulated by the Food and Drug Administration (FDA), unscrupulous manufacturers sometimes sneak ingredients in to the final product that aren't listed on the label.

The Grocery Manufacturers Association (GMA) issued the following statement from Dr. Leon Bruner, GMA's chief science officer, on the release today of a newNutrition Facts panel by the U.S. Food and Drug Administration (FDA):

As the deadline edges closer — June 18, 2018 — manufacturers must ensure that their products no longer contain PHOs for uses that have been otherwise authorized by the US Food and Drug Administration (FDA).

is that off - label uses for medications are supported by medical trials / testing, but lack of FDA - approval means the drug manufacturers can not * advertise * the off - label uses?

Earlier this summer, the Food and Drug Administration released new guidelines regarding the claims and information provided by sunscreen manufacturers.

The U.S. Food and Drug Administration (FDA) requires manufacturers of infant formula to analyze each batch to verify nutrient levels and stamp every container with a «use by» date — just like the ones found on milk, eggs, and other perishables.

If however many MDs aren't practicing evidence - based medicine, then why not don't MDs * police their own * before going off on other professions for their lack of evidence - base... or attacking what evidence - base there is even if it isn't multiple double - blind placebo controlled studies funded by wealthy drug manufacturers?

Although the American Academy of Pediatrics, the Food and Drug Administration, and the drug manufacturer have raised concern about the use of fluoxetine by women while breastfeeding and the drug manufacturer recommends against its use, these guidelines are based on little information.Drug Administration, and the drug manufacturer have raised concern about the use of fluoxetine by women while breastfeeding and the drug manufacturer recommends against its use, these guidelines are based on little information.drug manufacturer have raised concern about the use of fluoxetine by women while breastfeeding and the drug manufacturer recommends against its use, these guidelines are based on little information.drug manufacturer recommends against its use, these guidelines are based on little information.1, 2

Europe's food regulation agency, the European Union, does not allow the use of many ingredients still approved by the FDA and holds formula manufacturers to standards closer to that of drug manufacturers.

If you are a drug manufacturer, do you want to know how often your products have been mentioned in Parliament, by whom and in what context?

The Misuse of Drugs Act 1971, as amended by the Police Reform and Social Responsibility Act 2011, provides powers for enforcement agencies to deal with illicit manufacturers, suppliers and importers of temporary class dDrugs Act 1971, as amended by the Police Reform and Social Responsibility Act 2011, provides powers for enforcement agencies to deal with illicit manufacturers, suppliers and importers of temporary class drugsdrugs.

A study commissioned by the Pharmaceutical Research and Manufacturers of America — the trade organization representing the drug industry — warns that Cuomo's plan will drive up health care costs, harm New York consumers and could worsen the addiction crisis.

Refusal by the drug's manufacturer to release full details of their clinical trials, has forced the government to make a decision on stockpiling that is not based on the evidence.

The bill would prohibit smokable forms of the drug, and the compromise curtails both the number of manufacturers allowed to grow the drug and the companies that could dispense it, compared to the prior bill sponsored by Savino and Assembly sponsor Richard Gottfried.

A 2002 study in the Journal of the American Medical Association (JAMA) found that 87 percent of guideline authors received industry funding and 59 percent were paid by the manufacturer of a drug affected by the guidelines they wrote.

None of the consumer kits have officially undergone the rigorous testing process that a drug or medical device must undergo for approval by the U.S. Food and Drug Administration, and the purchaser has only the manufacturer's claim that it works for its intended drug or medical device must undergo for approval by the U.S. Food and Drug Administration, and the purchaser has only the manufacturer's claim that it works for its intended Drug Administration, and the purchaser has only the manufacturer's claim that it works for its intended use.

The FDA traditionally has taken a product - specific approach to drug approval decisions by focusing on the data generated and submitted by a drug's manufacturer and balancing the benefits against the known risks to the individual patient.

Any decisions about assigning metrics like letter grades to drugs — a step floated by FDA personnel in the past to indicate the quality of different manufacturers and pressure companies to improve — was not part of the plan.

The trial using medicines produced by Egyptian drug manufacturer Pharco Pharmaceuticals was run by DNDi and co-sponsored by the Malaysian Ministry of Health, in ten sites in Malaysia and Thailand.