Articles Tagged With: FDA
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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.
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FDA Streamlining COVID-19 Shot to a Single Formula
Conceding the various vaccine doses and multiple boosters have caused considerable confusion, and some degree of pandemic apathy, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to simplify and “harmonize” the process by switching to a single vaccine formula to be administered annually for most people.
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FDA’s Decision to Allow Pharmacy Sales of Mifepristone Faces Challenges
The decision by the FDA to permit retail pharmacies to dispense medication abortion pills could remove barriers related to time, distance, and costs for patients in states with laws legalizing abortion care. One possible risk is a lawsuit filed by the Alliance for Hippocratic Medicine, an anti-abortion group that claims the FDA did not approve mifepristone with sufficient scientific evidence.
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FDA Issues Draft Guidance on Lowering Lead Levels in Baby Food
If plan is implemented, the agency estimates it could result in a 24% to 27% reduction in exposure.
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FDA’s Change to Emergency Contraception Labeling Is Good News for Women
In a move that expands access to contraception, the FDA announced that it was changing packaging labels for Plan B, the emergency contraceptive pill that is available over the counter. The box no longer will carry the baseless claim that the pill may prevent a fertilized egg from implanting in the womb.
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What Happens if Post-Approval Studies Are Delayed or Do Not Show Benefit?
Essentially, the ethical issues are how to consider the interests of patients today, who are willing to accept uncertainty in the hopes a drug works because they do not have time to wait, and the interests of patients tomorrow, who would prefer to have stronger evidence about what works and what does not.
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Research Shows Pharmacists Can Easily Dispense Medication Abortion
The results of a recent study support allowing pharmacists to dispense mifepristone directly to people — like any other medication.
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Levonorgestrel IUDs Are Safe and Effective for Eight Years of Use
Two of the most popular hormonal IUDs can be used for eight years, which can make them an even better option for women seeking long-term, highly effective contraception.
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U.S. N95 Respirator Supply Finally Deemed Adequate
Federal regulators remove devices from shortage list.