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FDA Takes Action to Increase U.S. Supply of Personal Protective Equipment for Covid-19

March 24, 2020 By MedNews Leave a Comment

Today, the U.S. Food and Drug Administration (FDA) took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.

One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. The FDA is engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries. The FDA has adjusted its import screening to further expedite imports of legitimate products and are continually monitoring our import systems to prevent and mitigate any potential issues.

The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.

The agency is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready and available to engage with importers to minimize disruptions during the importing process.

Many companies are stepping up across America to help with manufacturing critical and life-saving medical supplies to strengthen the U.S. response. To support their efforts, we are setting up additional avenues of communication to FDA so they can contact us with any questions or concerns around the clock.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Filed Under: FDA News & Alerts

Final FDA Guidance Issued on Evaluation and Labeling of Abuse-deterrent Opioids

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. [Read more…]

Filed Under: FDA News & Alerts Tagged With: opioids

Use of CoreValve System for Aortic “Valve-in-Valve” Replacement Expanded

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. [Read more…]

Filed Under: FDA News & Alerts Tagged With: CoreValve System

Breath Test to Aid in Diagnosis of Gastroparesis Gets FDA Approval

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Advanced Breath Diagnostics, Gastroparesis

Corlanor Approved to Treat Heart Failure

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Amgen, Corlanor, Heart Failure

FDA Approves First Generic Copaxone to Treat Multiple Sclerosis

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). [Read more…]

Filed Under: FDA News & Alerts Tagged With: Copaxone, glatiramer acetate, multiple sclerosis, Sandoz

Corneal Implant to Improve Near Vision Wins FDA Approval

May 22, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery. [Read more…]

Filed Under: FDA News & Alerts Tagged With: AcuFocus Inc., Corneal Implant, KAMRA inlay

Illinois food company agrees to stop production of contaminated sprouts

May 21, 2015 By MedNews Leave a Comment

On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Wholesome Soy Products Inc.

FDA enters consent decree with Medtronic, Inc.

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. [Read more…]

Filed Under: FDA News & Alerts Tagged With: cancer, Medtronic, Pain Management, S. Omar Ishrak, Synchromed II Implantable Infusion Pump Systems, Thomas M. Tefft

FDA approves first generic Abilify to treat mental illnesses

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Ablify, aripiprazole, bipolar, schizophrenia

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