prescription drug Articles
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Risk information in prescription drug & medical device ads, promotional labeling – What the FDA expects
Abstract: The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices. This article gives an overview and summary of the ...
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What’s the 2019 DSCSA Requirement and Why Was it Delayed?
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA), which was enacted to enhance FDA’s ability to protect consumers from exposure to potentially harmful drugs. The act outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. New requirements ...
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America`s Painkiller Epidemic and What You Can Do
A new study conducted by the National Safety Council (NSC), along with Indiana’s attorney general has found that 80% of Indiana employers have been impacted by prescription drug misuse and abuse by employees. 80% is a substantial figure, causing some to refer to this trend as a painkiller epidemic. This figure is not unique to Indiana, the NSC notes that the results would likely be ...
By SafetyNow
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A comparative study of prescribing and transcribing between the women hospital pharmacy and the ASHP: a benchmark approach
The aim of this case study is to compare the performance of the Pharmacy Department in the Women Hospital of the Hamad Hospital Corporation (HMC) of Qatar, with that of the American Society of Health System Pharmacists (ASHP) national survey in terms of prescribing and transcribing of drugs that was conducted in 2001. The methods used in this case study include observation, secondary data ...
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What’s Next for DSCSA Dispenser Requirements?
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA) and is designed to protect consumers from potentially harmful drugs. New requirements roll out on November 27th of each year. Each new requirement progresses toward building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United ...
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Policy Management – DCSCA – Drug Supply Chain Integrity
When the Drug Quality and Security Act (DQSA) was signed by President Obama on November 27, 2013, advocates hoped that the confusing patchwork of State laws governing drug pedigree and tracing would finally be replaced by a comprehensive solution for the ‘3T’s’ (Transaction History, Transaction Statement, and Transaction Information) of the increasingly complex pharmaceutical ...
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G Protein-Coupled Receptors targeted by antibodies raised against three dimensional epitopes
Why target GPCRs with antibodies? The G Protein-coupled receptor (GPCR) superfamily represents the largest and single most important family of human drug targets. GPCRs play a central role in a plethora of biological processes and are linked to a wide range of therapeutic areas including cancer, diabetes, inflammation, cardiovascular diseases, and chronic pain. Expressed in every type of cell in ...
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Antacids, Prescription Drugs or Digestive Enzymes? Your Best Bet for Better Digestion
Upset stomach, heartburn, diarrhea? There are few symptoms as disruptive to your daily life as ones that originate in the digestive system. And if you’re struggling with any of these symptoms, you know exactly how difficult they are to get rid of for good. Doctors recommend a variety of treatments, but there are three biggies they suggest most often for patients who are dealing with both ...
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SmartTab Completes Successful Preclinical Animal Studies for TargetTab™ Platform
SmartTab is pioneering a wireless remote controlled drug delivery system, has completed pre-clinical animal studies and is preparing for human clinical trials for its core technology TargetTab™. This proprietary and patented wireless capsule will revolutionize targeted drug delivery and medicine adherence. DENVER, CO — Prescription pills are often delivered to the wrong site, at ...
By SmartTab
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Ranking Prescribed Pharmaceuticals in Terms of Environmental Risk: Inclusion of Hospital Data and the Importance of Regular Review
A newly available dataset on pharmaceuticals used in Scottish hospitals enabled an Environmental Risk Assessment that includes hospital consumption of pharmaceuticals, as previous UK rankings have been based on community prescription only. As health and the environment are devolved issues for the Scottish government, it is in any case merited to consider a Scottish ranking separately; regional ...
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How to Select Excipients in Drug Formulation?
The purpose of formulation development is to ensure that the drug is safe, effective, stable, and convenient to use. If the dosage form is improperly selected and if the prescription and process design are unreasonable, it will have a certain impact on the quality of the drug product, and even affect the drug’s efficacy and safety. Therefore, formulation research occupies a very important ...
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6 Best Practices to Help Achieve DSCSA Compliance
Many hospitals struggle to achieve optimal compliance with the Drug Supply Chain Security Act (DSCSA). The challenge to comply seems to come from an incomplete or inaccurate understanding of the regulations, which is understandable given the Act’s complexity. DSCSA was put in place to protect consumers from harmful drugs, such as those that are stolen or contaminated. The Act outlines ...
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Proposition 65: OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations
On August 28, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering "clear and reasonable warnings" requirements. Bergeson & Campbell, P.C. (B&C®) prepared a memorandum discussing OEHHA's November 27, 2015, proposed rule, Proposition 65: OEHHA Repeals and Re-Proposes Revisions to ...
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Adenocarcinomas and Their Often Misleading Symptoms When Dyspepsia Is an Indication of Cancer - Case Study
Medical History Jane is a 40-year-old, married mother of two teenage boys. She teaches at the local elementary school and has been in good health for most of her life. She has no surgical history. Her most severe ailment up to this point has been the flu at age 27. Her students are first-graders; they are often difficult to control. She also experiences the normal stresses of raising ...
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California Prop65 list
1. Tetrahydrocannabinol (THC) Tetrahydrocannabinol (THC) is an active ingredient in Nabiximols, a specific extract of Cannabis that was approved as a botanical drug in the United Kingdom since 2010 as a mouth spray for people with multiple sclerosis to reduce neuropathic pain, spasticity, overactive bladder, and other symptoms. Nabiximols (as Sativex) is available as a prescription drug in ...
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Pharmaceutical Companies Rely on Nitrogen
Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management. To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, ...
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The Science Behind Dietary Supplements: Exploring Efficacy and Safety of Popular Ingredients
Dietary supplements have become increasingly popular in recent years as individuals seek to optimize their health and well-being. When it comes to popular dietary supplement ingredients, several categories stand out, including vitamins, minerals, amino acids, enzymes, botanicals, and more. Each of these components plays a crucial role in supporting various physiological functions in the human ...
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Could a COVID Vaccine threaten an endangered species and impact human health in the process?
What do you find at the intersection of COVID-19 and endangered species? There is a joke in there somewhere, but if you’re drawing a blank I’ll fill it in for you: horseshoe crabs. Yes, believe it or not, these prehistoric, ocean-dwelling creatures may find themselves on the edge of extinction after a COVID-19 vaccine is mass-produced and distributed worldwide. These large, ...
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What’s a life-saving drug worth? It depends…
The risk? According to Medicinenet.com, only 5 in 5,000 drugs that enter preclinical testing advance to human trials. And only 1 of these 5 drugs ultimately gets approved for sale, which means the chance for a new drug to make it to market is 1 in 5,000. That’s a lot of R&D ...
By Vistex Inc
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B.C. Poultry Industry Warned to Halt Use of Antibiotic - Puroxi
Level of drug-resistant bacteria spikes in grocery-store chicken The Public Health Agency of Canada is warning B.C. poultry farmers and veterinarians to stop using a bovine antibiotic on chickens. The agency believes the practice is behind a significant spike in drug-resistant Campylobacter bacteria found in chicken tested from grocery stores. The bacteria are resistant to an antibiotic ...
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