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Flow restrictor on bottle necks helps prevent children from overdosing..Food and Drug Administration has endorsed the use of a safety device for bottles of children's medication containing liquid acetaminophen,…Called a flow restrictor, the device fits into the top of a bottle to prevent kids from inadvertently squeezing or sucking out too much liquid..

CVS Health Corp, the No 2 manager of drug benefit plans for U.S. employers and insurers, will wait until a second new cholesterol-lowering drug is approved by regulators before negotiating for price discounts or adding either of the much pricer new drugs to its list of covered medications.

Food and Drug Administration…revealed that it is working to build a software platform for precision medicine and an informatics community around it… contracted with DNAnexus, to create open source cloud-based software for sharing genomic information…will help..advance the science around the accuracy and reproducibility of next generation sequencing-based tests,..

Health system pharmacy managers…got a reprieve when the Food and Drug Administration moved the deadline for compliance with the Drug Supply Chain Security Act to November 1, 2015… outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed.. dispensers have to maintain tracing files – a document for every purchase transaction…

Food and Drug Administration has issued a new guide for parents about vaccinating their children. The online guide includes information about the benefits and risks of vaccination, the types of vaccines children routinely receive as well as a section with questions that parents are asking about vaccination.

…US regulator awards iclaprim expedited QIDP (fast-track qualified infectious disease product) status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy…This drug should not be developed further…the drug industry is forgetting past lessons about what constitutes good evidence…

Food and Drug Administration….published a final guidance regarding pediatric oral liquid OTC products containing acetaminophen to address…acetaminophen overdose associated with these products and to promote their safe use.

• single-ingredient acetaminophen oral liquids… use a concentration of 160 mg acetaminophen per 5 mL.
• the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented… same font size as the active ingredient name
• Dosing directions should be provided only in mL.
• recommended use age range should reflect the same age range as stated in the Drug Facts Panel under the heading "Directions"
• any images of children on the carton should also be representative of the age group identified under "Directions."

Food and Drug Administration says Kardashian's social media posts violate federal drug-promotion rules…they don't mention side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness…

Dr. John Halamka … sound the alarm on medical device threats in the wake of the FDA late last week issuing its first cybersecurity warning about a specific medical device…urged healthcare facilities to stop using Hospira's Symbiq Infusion System, a common device for dispensing fluids/drugs to patients…the devices could be accessed via a hospital network and rejiggered to mess up a patient's dosage….this will be the first of many advisories...involving medical device vulnerabilities.

Food and Drug Administration has approved the first three-dimensional printed oral drug product, Spritam (levetiracetam), from Aprecia Pharmaceuticals,…indicated as adjunctive therapy for partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy…was developed with Aprecia's proprietary ZipDose technology, which uses three-dimensional printing to create a porous formulation...that disintegrates rapidly...