Category: Regulations
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FDA Issues Covid-19 Variant Regulatory Guidance
Food and Drug Administration is updating its regulatory guidance for Covid-19 drugs and diagnostics to cover emerging mutations in the SARS-CoV-2 virus.
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20 Precision Meds Approved by FDA in 2020
A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020.
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FDA Clears Covid-19 Dual-Antibody Therapy
The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections.
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Essay – Find the Missing Vaccine Doses
Biden’s vaccine distribution team needs to find those doses, and fast, before their shelf life expires.
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Infographic – Most Americans Wearing Mask in Public
Wearing a face mask has become a hot-button public controversy in the U.S., but a continuing survey shows Americans by and large are wearing masks in public.
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Monthly HIV Drug Combo Approved by FDA
The Food and Drug Administration approved a drug regimen given once a month to control HIV infections, to replace daily antiretroviral medications.
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FDA Issues Precision Genomic Drug Guidance
The U.S. Food and Drug Administration issued draft administrative and procedural guidelines for genetic disorders treated with precise gene therapies.
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Trial OKed for Rare Disease Gene Therapy
A start-up biotech company says it received clearance from the Food and Drug Administration to begin a clinical trial of its gene therapy for Krabbe disease.
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FDA Begins Qualifying Non-Animal Testing Options
The Food and Drug Administration began a pilot program for assessing alternative technologies to test drugs, biologics, and devices without animals.
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Infographic – Public Favors Rejoining Paris Accord
A YouGov survey taken earlier this month indicates the U.S. public largely supports rejoining the Paris climate agreement.