Sunday, April 20, 2025

Sunday, April 20, 2025

Latest News

COHLEAR LIMITED: FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones

FDA Approval

By Press release submission | Jun 17, 2019

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.

BIO-TECHNE CORPORATION: FDA Grants Breakthrough Device Designation To Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test

FDA Approval

By Press release submission | Jun 17, 2019

Bio-Techne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

Regulation

By Press release submission | Jun 18, 2019

Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993

MICROBIOME THERAPEUTICS INNOVATION GROUP: Statement on FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

Regulation

By Press release submission | Jun 18, 2019

On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT

FOOD AND DRUG LAW INSTITUTE: Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues

By Press release submission | Jun 19, 2019

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Physician praises FDA plans to further assist doctors obtain experimental cancer treatments

FDA Approval

By Jenna Lyons | Jun 19, 2019

WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.

CARSGEN THERAPEUTICS: Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA

FDA Approval

By Press release submission | Jun 19, 2019

CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).

U.S. FOOD AND DRUG ADMINISTRATION: Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

Regulation

By Press release submission | Jun 20, 2019

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.

BECTON DICKINSON AND COMPANY: BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

Patients

By Press release submission | Jun 20, 2019

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA

FDA Update: Which drugs are in short supply?

Drug Shortages

By FDA Reporter Submission | Jun 20, 2019

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Guidance for premarket tobacco product applications for electronic nicotine delivery systems finalized

Regulation

By Keri Carbaugh | Jun 21, 2019

The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.

ZEBRA MEDICAL VISION: Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts

FDA Approval

By Press release submission | Jun 21, 2019

Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage (ICH), based on head CT scans.

GEL-E, INC.: Breakthrough Device Designation received from the FDA

FDA Approval

By Press release submission | Jun 21, 2019

gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.

FDA says foods with toxic PFAS chemicals are ‘not a concern’

Regulation

By Keri Carbaugh | Jun 22, 2019

Test results from the Food and Drug Administration on food with high levels of fluorinated chemicals known as PFAS were dismissed by two high level officials of the FDA.

Should FDA be allowed to share in the profits during its approval process?

Reform

By John Severance | Jun 22, 2019

A Hawaii doctor opined in a column if the Food and Drug Administration should share in pharmaceutical and medical research profit.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting

Reform

By Press release submission | Jun 24, 2019

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.

U.S., 27 EU nations join drug inspection accord

Regulation

By FDA Reporter Submission | Jun 27, 2019

As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.

Cannabis regulation not in FDA jurisdiction, industry expert says

Regulation

By John Severance | Jun 27, 2019

The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says FDA should lay off and let states do their jobs.

FDA approves new treatment for pediatric type 2 diabetes

FDA Approval

By Keri Carbaugh | Jun 29, 2019

The Victoza injection was approved by the U.S. Food and Drug Administration earlier this month for patients 10 years and older with type 2 diabetes.

National Center for Health Research wants clearer information disseminated on device predicates

Reform

By Keri Carbaugh | Jun 29, 2019

The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.

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  2. 2 BAYER: U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
FDA Reporter