Patient SafetyClinical DecisionSafety ProfileThe new US FDA regulation on safety reporting in clinical trials which became effective on 28 March 2011 will enhance patient safety and provide better data to support clinical decision making, say Dr Rachel Behrman Sherman and colleagues from the FDA. The...
the holder must collect information on suspected adverse drug reactions occurring abroad. Article 51 states that for serious adverse reactions occurring abroad, the holder must submit them in accordance with the requirements for individ...
Clinicians should use clinical judgment in assessing the risk for preeclampsia and discuss the benefits and harms of low-dose aspirin use with their patients. In October 2020, the US Food and Drug Administration released a safety drug communication warning that the use of nonsteroidal anti-...
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GlaxoSmithKline (GSK) pleaded guilty to criminal charges for allegedly promoting its drugs for unapproved uses and failing to report on the safety data abo... D Satish,BS Kumar 被引量: 0发表: 2013年 New standard of disclosure set for clinical trials an agreement with GlaxoSmithKline to settle...
Screening adults for depression in primary care: a position statement of the American College of Preventive Medicine. J Fam Pract. 2009;58(10):535-538.PubMedGoogle Scholar 68. Trangle M, Gursky J, Haight R, et al. Adult Depression in Primary Care. Institute for Clinical ...
In certain limited circumstances, we may need to disclose your personal data to comply with a legal obligation, process, or demand and for reasons of public interest, such as to comply with reporting obligations to our governing regulatory authorities regarding the safety of our products, in respo...
In June 2023, the phase 1 clinical study of ALXN2220 to treat ATTR-CM was published in the “New England Journal of Medicine”. The study results showed that the safety of ALXN2220 was still good at the highest test dose, and no significant dose-limiting toxicity or serious drug-related ...
vulnerabilities. As the ANPRM argues, even if an individual component or system has a benign and highly specific function for the safety and operationality of the vehicle, such devices or software may create an entry point for a state-backed cyber actor to infiltrate the US transportation sy...
Eugene Gamble, a U.K.-trained periodontist who has conducted his own clinical trials. "Even with extensive explanation, some people are a little unsure about the safety of what is being undertaken and the phrase 'so I'm a guinea pig' has been used more than once." However, by the ...