Archives for February 2018

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.