HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


US Extends Enforcement Discretion For Infant Formula Production With Guidance For Compliance

Executive Summary

Guidance extends through Jan. 6 enforcement discretion for formula products cleared for sales under temporary guidance FDA announced in May. Further extensions possible for firms taking steps toward lawful marketing of products in US, agency says.

You may also be interested in...

USDA Examines Potential Production Regulation Changes To Prevent Powder Formula Contamination

USDA Food Safety and Inspection Service’s National Advisory Committee on Microbiological Criteria for Foods schedules hearing for 15 November to consider a report from FDA on presence of Cronobacter species bacteria in powder formula products.

US FDA Plans Streamlining Infant Formula Approval Process To Expand Supply Chain

FDA “determined a more streamlined pathway” using information it's received for  products available under enforcement discretion “would help provide for the long-term availability and marketing of many” of those products.

Abbott’s Earnings Guidance Unchanged With Questions On Formula Recall Unanswered

Latest announcement about recall not reported in SEC filing came in FDA posting of Abbott’s announcement concerning an expansion of firm’s recall to include an additional lot of Similac powder.


Latest News
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts