Friday, May 17, 2024

Friday, May 17, 2024

Latest News

MEDICAL MARIJUANA, INC.: CEO Chosen to Present Oral Comments at FDA's Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds

Regulation

By Press release submission | May 21, 2019

Medical Marijuana, Inc. (OTC: MJNA), the first publicly traded cannabis company in the United States, announced today that the Company's CEO, Dr. Stuart Titus, has been chosen as one of 65 speakers to present oral comments at the U.S. Food & Drug Administration (FDA)'s upcoming public hearing discussing scientific data and information about products containing cannabis-derived compounds.

U.S. FOOD AND DRUG ADMINISTRATION: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

Regulation

By Press release submission | May 22, 2019

U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities

Regulation

By Press release submission | May 22, 2019

U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development.

Former commissioners promote idea of an independent FDA

Regulation

By Keri Carbaugh | May 22, 2019

This week, Eli Adashi, Rohit Rajan, and Glenn Cohen will have another paper published in Science that says the FDA is being undermined because of politically motivated congressional legislators, especially recently.

Health policy expert rejects suggestion of FDA independence

Reform

By John Severance | May 22, 2019

Two papers written by seven former FDA commissioners suggest the organization should become an independent agency.

Arizona doctor disagrees with FDA papers that claim agency should be indepedent

Reform

By John Severance | May 22, 2019

Seven former Food and Drug Administration commissioners suggested in a couple of articles that the FDA should become an independent agency

THINK SURGICAL, INC.: Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures

FDA Approval

By Press release submission | May 23, 2019

THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement procedures.

EPIBONE, INC.: Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

FDA Approval

By Press release submission | May 23, 2019

Potential breakthrough technology for stem-cell based bone replacement

FDA warns of unapproved diabetes devices

Regulation

By Keri Carbaugh | May 23, 2019

In a safety communication released last week, the Food and Drug Administration warned against unapproved and unauthorized devices for diabetes.

REGENXBIO: Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform

FDA Approval

By Press release submission | May 24, 2019

FDA approval of Novartis' ZOLGENSMA for the treatment of pediatric patients with SMA marks the first regulatory approval based on REGENXBIO's NAV Technology

OCTAPHARMA USA: FDA Approves New Octaplas™ Product Label

Patients

By Press release submission | May 24, 2019

New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients

CONTROLRAD, INC.: Announces FDA Clearance and Launch of the Only Radiation Reduction Technology that Integrates into Mobile C-arms

FDA Approval

By Press release submission | May 25, 2019

The ControlRad Trace solution reduces unnecessary radiation up to 89%, protecting patients and medical staff without compromising image quality or workflow.

Cook, Los Angeles, Miami-Dade counties most at risk of measles outbreak, study finds

Patients

By FDA Reporter Submission | May 26, 2019

Illinois’ Cook County is the U.S. jurisdiction most at risk of a measles outbreak this year, according to a study published this month in the British medical journal The Lancet Infectious Diseases.

SOLITON, INC.: Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device

FDA Approval

By Press release submission | May 28, 2019

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"), announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market its Rapid Acoustic Pulse ("RAP") device for tattoo removal.

NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals receives consecutive FDA approvals for their generic versions of Solifenacin and Trientine

FDA Approval

By Press release submission | May 28, 2019

It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of The MSN Group (MSN) based in Hyderabad, India.

COTA, INC.: Signs Research Collaboration Agreement With The U.S. Food and Drug Administration

FDA Approval

By Press release submission | May 29, 2019

Collaboration Aims to Study Variation in Cancer Treatment Patterns by Extracting and Analyzing Real-World Data

INOVA DIAGNOSTICS: QUANTA Flash RF IgM and IgA receive FDA clearance

FDA Approval

By Press release submission | May 29, 2019

Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA).

Iowa congressman praises FDA's decision to extradite treatment for woman battling rare form of ALS

FDA Approval

By John Suayan | May 29, 2019

U.S. Rep. Steve King (R-Iowa) praised the Food and Drug Administration for its decision to speed up treatment for a 25-year-old Iowa woman battling amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Regulation

By Press release submission | May 30, 2019

The opioid tragedy has become one of the defining public health crises of modern times.

NUTEK FOOD SCIENCE: To Transition Potassium Salt Labeling Initiative to New FDA Docket

Regulation

By Press release submission | May 30, 2019

NuTek Food Science, LLC, a company that helps create great-tasting and affordable foods to enhance global health and wellness, announced that it is withdrawing its widely supported and highly publicized citizen petition concerning potassium salt that was filed with the FDA in 2016.

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