FDA Press Releases RSS Feed

  • FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

    FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

    FDA takes several steps to make the use of laparoscopic power morcellators safer in gynecologic surgeries: grants marketing authorization for updated labeling, releases draft guidance and issues a...

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  • Coronavirus Update: FDA steps to ensure quality of foreign products

    Coronavirus Update: FDA steps to ensure quality of foreign products

    Coronavirus Update: FDA steps to ensure quality of foreign products

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  • FDA approves first generic of ProAir HFA

    FDA approves first generic of ProAir HFA

    FDA has approved an application for the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol.

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  • FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

    FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

    Today, FDA authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual...

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  • FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

    FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

    FDA is providing its view of the state of the current science in pharmacogenetics. FDA’s new web-based resource describes some of the gene-drug interactions for which it believes there is...

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  • FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

    FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

    Today, the U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products, as well as certain other...

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  • Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

    Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

    Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC,...

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  • FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

    FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

    The FDA announced that in partnership with the Government of India, approximately 500 shipments of illicit and potentially dangerous, unapproved prescription drugs and combination medical devices...

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  • FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

    FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

    FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

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  • FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    FDA is an active partner in the COVID-19 response, working closely with government and public health partners across HHS and international counterparts.

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  • FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

    FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

    Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

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  • FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

    FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

    FDA analysis published today advances the understanding of intentional genomic alterations in animals.

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  • FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnost

    FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnost

    Today, FDA issued an EUA to enable emergency use of CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows...

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  • FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to

    FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to

    The U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products.

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  • FDA approves first drug for treatment of peanut allergy for children

    FDA approves first drug for treatment of peanut allergy for children

    FDA approves first drug for treatment of peanut allergy for children Treatment with this product may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut...

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  • FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through inc

    FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through inc

    FDA launches an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief...

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  • FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

    FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

    FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

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  • FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

    FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

    FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

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  • FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

    FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

    FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not...

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  • FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical

    FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical

    FDA is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central...

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