FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/4/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 10/4/2019.

Federal Register

Panel to Review Jardiance sNDA

Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehringer Ingelheim supplem...

Human Drugs

FDA Funding for Drug Safe Use Research

As part of FDAs Safe Use Initiative, CDER director Janet Woodcock announces a funding opportunity for individuals and organizations to conduct further...

FDA General

FDA Warns Against Vaping THC as Injuries Rise

FDA updates a consumer alert to warn against using vaping products containing THC as the latest number of reported cases and deaths associated with va...

Biologics

DBV Tech BLA for Peanut Allergy Immunotherapy

FDA accepts for review a DBV Technologies BLA for its investigational Viaskin peanut immunotherapy for treating peanut-allergic children ages four to ...

Human Drugs

Trump Claims Pharma Industry Supporting Impeachment

President Trump claims that the pharmaceutical industry is secretly plotting the demise of his presidency and supporting the current impeachment inqui...

Federal Register

Clinical Data Standards Pilot: Correction

Federal Register notice: FDA corrects a notice that appeared in 8/20 Federal Register announcing a Fit for Use Pilot Program Invitation for the Clinic...

Human Drugs

AstraZeneca Self-administration Fasenra Approved

FDA approves AstraZenecas self-administration version of Fasenra (benralizumab) Pen in a pre-filled, single-use auto-injector as an add-on maintenance...

Medical Devices

United Health Products PMA for HemoStyp

United Health Products files a PMA for HemoStyp, an absorbable hemostatic dressing for use in abdominal, cardiovascular, thoracic and vascular surgica...