Monday, April 6, 2020

Monday, April 6, 2020

Latest News

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 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.

ORAMED: Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive feedback from its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss Chemistry Manufacturing and Control (CMC) of its lead oral insulin capsule ORMD-0801.

JANSSEN: Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS).

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

New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials

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

We are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak.

U.S. FDA: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts.

VIZIENT: Comments Support FDA’s Efforts to Expedite Biosimilar Insulin Development

Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”

U.S. FDA: FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.

FDA Health News