Tags » FDA

Despite regulatory troubles, DNA testing firm 23andMe raises more money

DNA testing and genome sequencing startup 23andMe has raised a fresh $80 million in new funding, according to a new regulatory filing.

According to the document, the company is seeking to raise a total of $150 million, so it still has about $70 million left to go. 257 more words

Tech

Natural Grocers Caribbean Nut & Fruit Mix Recall [US]

US/Silver Spring: Vitamin Cottage Natural Food Markets Inc. recalls certain Natural Grocers brand Caribbean Nut & Fruit Mix packages due to possible Salmonella contamination, a serious health hazard. 299 more words

Food

FDA clears drug for leading form of cystic fibrosis

WASHINGTON – Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. 608 more words

World

Webinar On Understanding the FDA’s Quality System Regulation, 21 CFR, Part 820

Scheduled On : Wednesday, July 29, 2015 at 13:00 Hrs 

Description :

Compliance with 21 CFR, Part 820 (the FDA’s Quality System Regulation) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. 265 more words

Medical Device

Webinar On Application of Lean Six Sigma Methodology for Regulated Industries

Scheduled On : Monday, July 27, 2015 at 13:00 Hrs     

Description :

This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. 311 more words

Life Science

Webinar On 9 Required Elements of Design Control System

Scheduled On Wednesday, July 22, 2015 at 13:00 Hrs

Description :This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. 144 more words

Medical Device

Webinar On Best Practices for Communicating and Interacting with FDA Reviewers

Scheduled On : Friday, July 17, 2015 at 13:00 Hrs

Description :

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. 243 more words

Life Science