Monday, March 30, 2020

Monday, March 30, 2020

Latest News

FDA: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

As part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.

FDA: Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity

Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

SOLITON: Files Special 510(k) with FDA for its Generation II RAP Device

Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration ("FDA") for its Generation II Rapid Acoustic Pulse ("RAP") device.

GOJO: Takes Immediate Action on Communication from the FDA

GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.

AAO: Reports Congressmen Write Letter to the FDA and FTC Regarding SmileDirectClub, While California Board of Dentistry Moves to Dismiss SmileDirectClub's Lawsuit

The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."

U.S. FDA: Michigan-based food manufacturer agrees to stop production after repeated food safety violations

U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

SURGLASSES: Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment

Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies.

CORREVIO: Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events

Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), an anti-arrhythmic drug for the conversion of atrial fibrillation (AF).

JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON: Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare's (ViiV) New Drug Application for the two-drug long-acting (LA) injectable regimen of ViiV's cabotegravir and Janssen's rilpivirine for the treatment of HIV-1 infection in adults. The regimen was co-developed as part of a collaboration between Janssen and ViiV.

VIIV HEALTHCARE: Receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

U.S. FDA: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.

U.S. FDA: California-based food manufacturer agrees to stop production after repeated food safety violations

The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

FDA Reporter