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Featured


COVID-19 BIVALENT VACCINE BOOSTERS

Now Authorized for Younger Age Groups


FDA HEARING ON THE CENTER FOR DRUG EVALUATION AND RESEARCH’S PROPOSAL TO
WITHDRAW APPROVAL OF MAKENA OCCURRING ON OCTOBER 17-19, 2022



Click here for Webcast Information


FEATURED TOPICS


CORONAVIRUS DISEASE 2019 (COVID-19)

FDA is working with U.S. government partners, including CDC, and international
partners to address the pandemic.


FDA MONKEYPOX RESPONSE

The FDA’s multipronged response to monkeypox includes efforts in the areas of
diagnostics, vaccines and therapeutics.


INFANT FORMULA INFORMATION AND RESOURCES

The FDA continues to work around the clock with our government partners and
industry to ensure there's adequate infant formula available wherever and
whenever parents and caregivers need it.


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RECENT PRESS ANNOUNCEMENTS

Nov 08


FDA ROUNDUP: NOVEMBER 8, 2022

Nov 07


FDA COMMISSIONER TESTS POSITIVE FOR COVID-19; EXPERIENCING MILD SYMPTOMS

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RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS

The FDA provides information gathered from press releases and other public
notices about certain recalls of FDA-regulated products. Not all recalls have
press releases or are posted on this website

Nov 08


SEVEN SEAS INTERNATIONAL USA, LLC VOLUNTARILY RECALLS GIANT FOOD PRIVATE LABEL
WILD CAUGHT ALASKAN SOCKEYE SMOKED SALMON BECAUSE OF POSSIBLE HEALTH RISK

Food & Beverages

Nov 07


COMERCIALIZADORA PEPSICO S. DE R.L. DE C.V. ISSUES VOLUNTARY RECALL OF GAMESA®
ARCOIRIS MARSHMALLOW COOKIES DUE TO POSSIBLE HEALTH RISK

Food & Beverages

Nov 05


ADAM’S POLISHES, LLC ISSUES VOLUNTARY NATIONWIDE RECALL OF HAND SANITIZER DUE TO
POTENTIAL CONTAMINATION WITH METHANOL

Drugs

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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS


FDA CONTINUES TO ADVANCE MEDICINES FOR CHILDREN

Increasing the availability of safe and effective medicines for children is a
key priority for the U.S. Food and Drug Administration.


FDA SEEKS FEEDBACK ON DISTRIBUTED AND POINT-OF-CARE DRUG MANUFACTURING

These technologies could potentially provide flexibility for drug manufacturers
to increase timely access to quality drugs.


FDA RELEASES NEW, PREVENTION STRATEGIES TO ENHANCE FOOD SAFETY

The strategies contain recommendations to guide the work of preventing future
foodborne illnesses.

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RECENTLY PUBLISHED GUIDANCES

Nov 08


SAMENESS EVALUATIONS IN AN ANDA — ACTIVE INGREDIENTS

Drugs

Nov 04


M10 BIOANALYTICAL METHOD VALIDATION AND STUDY SAMPLE ANALYSIS

Drugs

Nov 04


STUDYING MULTIPLE VERSIONS OF A CELLULAR OR GENE THERAPY PRODUCT IN AN
EARLY-PHASE CLINICAL TRIAL

Biologics

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