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U.S. FOOD AND DRUG ADMINISTRATION: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

As part of the U.S. Food and Drug Administration’s mission to protect the public health, outlined in our Medical Device Safety Action Plan, we are committed to continuing to strengthen and modernize how we take action to address device safety issues that emerge in the post-market in a more timely and effective way.

ISOTHRIVE LLC: ISOThrive's Novel Microbiome-Inspired GERD Therapeutic Begins FDA Drug Approval Path

New Solution, Not Based on Acid Reduction, Found to Relieve Symptoms, Believed to Restore Localized Distal Esophageal Microbiome

Responsible innovation in dietary supplements to be discussed at FDA public meeting

As part of a continuing effort to modernize and reform the oversight of dietary supplements, the Food and Drug Administration announced a public meeting on May 16 from 8:30 a.m. to 4 p.m. to canvass ideas on facilitating responsible innovation.

Revamped FDA website to launch this week

Food and Drug Administration Acting Commissioner Ned Sharpless announced a new FDA.org website to launch this week.

SYSTECH INTERNATIONAL: Optimal Solution team selected for FDA DSCSA Pilot Program

"The Optimal Solution" is a team of seasoned industry innovators cooperatively leveraging their expertise to demonstrate interoperability at scale in the pharma supply chain ecosystem. Team members include: RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk and CalQLogic.

BELITE BIO, INC.: Announces FDA Approval of Investigational New Drug (IND) for Phase 1 Clinical Trial of LBS-008 to Treat Macular Degeneration and Stargardt Disease

Belite Bio, a drug development company targeting currently untreatable conditions in ophthalmology and metabolic diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for LBS-008 (BPN-14967), a first-in-class oral therapy for the treatment of atrophic Age-related Macular Degeneration (commonly known as dry AMD) and Stargardt disease, an inherited juvenile form of macular degeneration.

Rising number of FDA advisory positions left unfilled

The number of vacancies on U.S. Food and Drug Administration advisory committees ticked upward during the final months of 2018, according to the agency’s most recent numbers.

PHILLIPS-MEDISIZE: Expands FDA Compliant Medical Manufacturing Capacity to Support Growing Customer Needs

Phillips-Medisize, a Molex company, today announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA. The facility is FDA 21 CFR part 820 compliant.

CURRENT HEALTH: Receives FDA Clearance for its Remote Patient Monitoring Solution for In-Home Care, Demonstrates Reduced Hospital Readmissions

Company growth and customer adoption continues with hospitals and home healthcare agencies as the industry shifts to community-centric, value-based care

SIMULATIONS PLUS, INC.: FDA Purchases Bundle of ADMET Predictor® Licenses

Center for Tobacco Products incorporates machine learning platform to assist toxicology research

SURGICAL INFORMATION SCIENCES: Announces FDA 510(k) Clearance for Additional Visualization Capabilities in its DBS Targeting Software

Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market new visualization capabilities.

VIVAQUANT: Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device

VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device.

RENALYTIXAI: FDA Grants Breakthrough Device Designation to KidneyIntelX™

Provides Priority Regulatory Review of AI-Enabled Diagnostic for Fast-Progressing Kidney Disease

FDA to host hearing on cannabis products

The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.

Regulatory Education for Industry Annual Conference to be held in Boston

The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.

North Carolina House introduces stem cell therapy bill

A bill proposing the right to try adult stem cell treatments was introduced in the North Carolina House on April 22.

FDA Reporter