Articles Tagged With: FDA
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FDA Approves New COVID Vaccine for Fall
COVID-19 advisors to the FDA voted unanimously to approve a new monovalent vaccine for the coming fall containing the currently predominant omicron subvariant XBB.1.5.
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FDA’s Final Decision on OTC Birth Control Pill Expected Soon
The unanimous endorsement of over-the-counter Opill norgestrel tablets by the joint advisory committee of the FDA may put the birth control pill on pharmacy shelves later this year.
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COVID-19: CMS Ends Vaccine Mandate for HCWs
The end of the COVID-19 national Public Health Emergency brought a highly controversial issue to a relatively quiet hiatus: Healthcare workers are no longer federally mandated to receive the SARS-CoV-2 vaccine. The Centers for Medicare & Medicaid Services has ended the requirement, which in any case did not apply to boosters or the bivalent vaccines.
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AOHP Researchers Track Down Needlestick Hazards
Following an alert from an occupational health manager at a U.S. hospital, researchers with the Association of Occupational Health Professionals in Healthcare found a longstanding sharps injury problem with prefilled syringes that were designed as safety devices.
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Telehealth and Mail Order Do Not Delay Use of Abortion Medication
Patients who met with reproductive health providers via telehealth and received medication abortion pills through the mail used the medication in a similar time frame as people who visited clinics in person, according to a recent study.
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RSV Vaccine for Older Patients Receives Support
FDA approved Arexvy to protect people age 60 years and older against the respiratory syncytial virus.
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FDA Panel Greenlights RSV Vaccine for Elderly
With some concerns and caveats that put a strong emphasis on post-marketing surveillance, vaccine advisors for the Food and Drug Administration have greenlit two vaccines against respiratory syncytial virus infections in people aged 60 years and older.
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Access to Mifepristone Still in Legal Limbo
A federal judge may block the use of the safe and effective abortion drug mifepristone after hearing a lawsuit by an anti-abortion organization. The group claimed the FDA had improperly approved mifepristone in 2000.
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FDA Adopts Flu-Like Plan for an Annual COVID Vaccine
The Food and Drug Administration took a decisive step recently in pivoting to fight COVID-19 with an approach similar to that used for decades against influenza, a seasonal virus for which a vaccine is concocted annually based on the circulating strains.
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More Transparency Might Bolster Trust in FDA Advisory Committees
The FDA does not always convene an advisory committee meeting in connection with application reviews, but may do so when questions related to safety or the data submitted to support approval arise. In the modern environment, some believe if they cannot see it, foul play must be afoot. Some of that could be allayed by transparency and more public education.