FDA: Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
The following quote is attributed to Jeffrey Shuren M.D., J.D., director of FDA's Center for Devices and Radiological Health
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3 SEASONS CAPITAL LLC: Heru, Inc., A 3 Seasons Capital, LLC Portfolio Medical Technology Company, Receives Class 1 Listing With the FDA for Developing a Next-Generation, Artificial Intelligence (AI)-Driven Platform for Vision Diagnostics and Augmentation
Heru, Inc., a 3 Seasons Capital, LLC portfolio medical technology company, has received Class 1 listing with the U.S. Food and Drug Administration (FDA) registration for developing a next-generation, artificial intelligence (AI)-driven platform for vision diagnostics and augmentation. Heru is the first diagnostic application for visual field exams.
FDA: Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.
CANNABICS PHARMACEUTICALS: Initiates In-Vivo Animal Studies for FDA Pre-IND Meeting Package
Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has initiated a series of proof of concept (POC), in-vivo, animal model studies to test its drug candidate RCC-33 on mice transplanted with colorectal cancer tumor cell lines.
NSC: National Safety Council Statement on the FDA Advisory Panel Approval of COVID-19 Vaccine and Employers' Subsequent Role
The National Safety Council applauds today's formal recommendation of the Pfizer COVID-19 vaccine and the CDC recommendations that prioritize distributing the vaccine first to healthcare personnel and long-term care facility residents, who need it most urgently.
VERANTOS: Receives FDA Support to Demonstrate Advanced Approaches to Real-World Evidence
Verantos today announced it has received a grant award from the U.S. Food and Drug Administration (FDA) to implement a multi-year advanced real-world evidence (RWE) study.
WHOLISTIC PEDIATRICS & FAMILY CARE: Dr. David Berger of Tampa to Address FDA COVID-19 Vaccine Approval Committee Regarding Public Concerns and Hesitations
Dr. David Berger of Wholistic Pediatrics & Family Care presents to the FDA's vaccine approval committee regarding alleviating public concerns and hesitations.
PRESSURE BIOSCIENCES: Proposed Acquisition Partner Cannaworx, Inc. Announces December 2020 Launch Date for FDA Registered Immune Booster
Designed to Help the Immune System Provide Important Protection Against Invading Pathogens
JANSSEN: Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Expanded Access Program Established for Patients in the U.S. Who May Benefit from Investigational Therapy While Application is Under Review
APPLIED DNA: Significantly Expands Addressable Market for Linea™ COVID-19 Assay Kit via Successful Amendment to FDA EUA
- Company Updates on Progress of Applied DNA Clinical Laboratories CLEP-CLIA Certification -
How Maryland Smith Is Helping the FDA Think About Drug Manufacturing and Risk
Pandemic-era disruptions underscored a troubling reality in the pharmaceutical industry – an outsized reliance on foreign manufacturers for the raw ingredients for drugs sold in the United States.
HAWKEYE SYSTEMS: Announces Letter of Intent to Secure Three-Year FDA Approved Nitrile Glove Supply
Hawkeye Systems, Inc. (OTCQB: HWKE)("Company"), a technology holding company focused on pandemic management products and services, is pleased to announce today it has signed a Letter of Intent (LOI) with Whistler International Korea, a leading multinational conglomerate located in Seoul with operations in Asia, Middle East and Latin American Countries.
ACUPATH LABORATORIES, INC.: KDx Selects Acupath as Lab for URO17™ FDA Clinical Trial
Innovative Bladder Cancer Biomarker Demonstrates Compelling Clinical Utility
SAFETY FIRST HEALTHCARE: CEO Shaun G. Morgan on the Extensive Offering of FDA-Certified Medical Products
Safety First Healthcare, a Delaware registered company registered with the Securities & Exchange Commission as a US-form 10 public company with factories in Vietnam specializing in the personal protective equipment business, offers an extensive range of personal protective equipment with FDA certifications for the medical community and the general public.
IHRC, INC.: To help FDA advance laboratory safety and security
On September 30, 2020, the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (DHHS) awarded IHRC, Inc. a 5-year, indefinite delivery/indefinite quantity contract, with a ceiling value of $49.5 million to provide support to the Office of Laboratory Safety (OLS).
FDA: Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations.
CANNABICS PHARMACEUTICALS: Prepares to Submit the FDA with a pre-IND Meeting Request for its Proprietary Colon Cancer Drug Candidate, CANNABICS™ RCC-33
Cannabics Pharmaceuticals Inc. recently issued the following announcement.Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has signed an agreement with a leading clinical quality and validation processes consultancy to oversee the preparation and submission of a Pre-IND Meeting request to the FDA on its anti-tumor Drug Candidate CANNABICS™ RCC-33, the world's first cannabinoid-based antitumor Drug Candidate for the treatment of Colorectal Cancer.