- FDA issues vaccine guide for parents (drugstorenews.com)Vaccines for Children - A Guide for Parents and Caregivers (fda.gov)
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.
- Amarin wins injunction against FDA in free speech case (fiercepharma.com)Amarin case could unleash a flood of off-label promos (fiercepharmamarketing.com)
Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for…not clear how big a victory the ruling will be given it came in a lawsuit Amarin brought against the FDA as a defensive move.
- Prominent healthcare CIO: FDA medical device security warning “will be the first of many” (networkworld.com)
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.
- FDA Unveils User Fee Rates for FY2016 (raps.org)
1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. The problem, FDA argued, lacked adequate funding to hire the staff it needed to review drugs in a more timely manner….solution FDA proposed was to collect one-time fees from the companies it regulates…. led to…Prescription Drug User Fee Act…
- FDA issues warning against Kim Kardashian’s drug promotions (cbsnews.com)Promotional Material (fda.gov)WARNING LETTER (fda.gov)
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…
- Concerns about FDA IT security persist House committee report says (in-pharmatechnologist.com)Information Security at the Department of Health and Human Services (energycommerce.house.gov)
While the breach did not result in substantial harm...it highlighted the susceptibility of FDA’s network to attacks and raised questions about the adequacy of FDA’s information security program…The vulnerability of information collected and maintained by the agency is of prime importance to many in the pharma and biotech industries because FDA has the legal obligation to protect companies’ trade secrets and confidential commercial information.
- FDA unveils precision medicine platform (healthcareitnews.com)Advancing precision medicine by enabling a collaborative informatics community (blogs.fda.gov)
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,..
- FDA Issues Guidance on Outsourcing Registration (pharmtech.com)
FDA released guidance… directed at companies that are considering registering with the agency as an outsourcing facility under…the Federal Food, Drug, and Cosmetic Act… guidance is in response to questions the agency received from companies about which activities (e.g., drug compounding) would require a company to register as an outsourcing facility and, therefore, be subject to registration fees…
- FDA veteran questions sciences behind antibotics fast track (in-pharmatechnologist.com)
…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…
- FDA issues final guidance on liquid pediatric acetaminophen (drugstorenews.com)
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."