FDA’s Gottlieb outlines new goals in budget plan, looking to spur drug reviews

President Donald Trump’s budget sought a boost in funding for the FDA and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plans to pursue.

Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital health.

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release

January 29, 2018

Contact

Consumers

Recall Department
recall@kareway.com
310-532-0009

 

Announcement

Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

An Analysis Of FDA FY2017 Drug GMP Warning Letters

By Barbara Unger, Unger Consulting Inc.

FDA Provides Some Guidance for 503B Facilities

 

On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.

FDA Releases Compounding Priorities Plan

The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.

Top Organizations Urge a Concerted Effort To Improve Safety in Hospital Compounding

Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was released today reflecting the recommendations of major stakeholders for additional steps needed to improve patient safety relative to compounded medicines.  The paper was the outcropping of a milestone dialogue where top pharmacy, healthcare provider, hospital and patient organizations assessed progress made since the 2012 NECC tragedy and the subsequent enactment of the Drug Quality and Security Act by Congress.

FDA Unveils Guidance To Smooth Generic-Drug Path

Law360, New York (January 3, 2018, 5:48 PM EST) — The U.S. Food and Drug Administration on Wednesday unveiled draft guidance for the pharmaceutical industry and an internal manual of policies and procedures that it says will streamline the approval process for generic drugs, in part by reducing the number of times an application must be reviewed.

Compounding Aseptic Containment Isolator from Aseptic Enclosures

We would like to start the New Year by introducing our Compounding Aseptic Containment Isolator. These close isolators provide a better physical barrier to protect the health of laboratory workers, maintain the sterility of experimental materials, and prevent the contamination of the environment. Closed containment cabinets are safer to use in research laboratories to provide a clean work environment, prevent exposure of laboratory personnel, prevent aerosol contamination, avoid pathogenic microorganisms to escape or enter the cabinet, prevent cross-contamination of experiments, and protect the environment.

Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues

For Immediate Release

November 30, 2017

Contact

Consumers

Simple Diagnostics
1-877-342-2385

Announcement

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

FDA Announces Approval, CMS Proposes Coverage Of First Breakthrough-Designated Test To Detect Extensive Number Of Cancer Biomarkers

Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner