Wednesday, April 8, 2020

Wednesday, April 8, 2020

U.S. Food and Drug Administration (FDA) News

FDA: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

The U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturersExternal Link Disclaimer importing personal protective equipment and other devices.

FDA: Insulin Gains New Pathway to Increased Competition

A historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

FDA: Coronavirus (COVID-19) Update: Daily Roundup March 27, 2020

The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic

FDA: Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020

The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic

FDA: Coronavirus (COVID-19) Update: Daily Roundup, March 25, 2020

The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic

FDA: Coronavirus (COVID-19) Update: Daily Roundup, March 24, 2020

The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic

FDA: Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

FDA: Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

FDA: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.

FDA: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

FDA: Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.

FDA: Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp

U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

FDA: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher

Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19).

FDA: Approves First Treatment for Group of Progressive Interstitial Lung Diseases

The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

FDA: Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications

New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials

FDA: Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).

FDA: Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel

In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings.

FDA: Approves New Therapy for Patients with Previously Treated Multiple Myeloma

The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

FDA: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

FDA Health News