Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction
UsernamePublicRestriction

GMP update

This article was originally published in The Tan Sheet

Executive Summary

Dietary supplement good manufacturing practices should not be expected to come out before the end of the year, "but certainly we should be able to get them out shortly after that," according to FDA Associate Commissioner for Regulatory Affairs Margaret O'K. Glavin. "It's really important those GMPs get out and get out expeditiously. [Center of Food Safety & Applied Nutrition Director] Bob Brackett chatted with me last week about this and how interested he is in making sure those are out there. They're important to us; they're important to you," she stressed at the Council for Responsible Nutrition's annual conference Sept. 18. O'K. Glavin encouraged members of the supplement industry to voice their desire for GMPs to regulators. "Certainly if you would continue to make known your strong desire to get those issued, that would not hurt in the least." She emphasized that regulatory processes are slow, "but where there is this confluence of the regulatory agency and the regulated industry both interested in getting them out that should make a huge difference"...

You may also be interested in...



Dietary Supplement GMPs Back To FDA; Publication Expected In June

Dietary supplement good manufacturing practices have received final clearance by the Office of Management and Budget, OMB and FDA confirmed May 9

EMA's Decision On Ranitidine Remaining Available Could Come At End Of April

Following the US request for ranitidine drugs to be withdrawn from the market, the European Medicines Agency says it would decide the fate of the products in the EU after wrapping up its own inquiry.

Perrigo Has Approval For Copy Of OTC Voltaren Arthritis Relief Before GSK Launches The Brand

Perrigo will launch generics of GSK's OTC Voltaren Arthritis Pain drug later in 2020 following FDA approval of its ANDA. GSK, which received FDA's OTC switch approval in February, still hasn't launched the product or indicated when it will.

Topics

UsernamePublicRestriction

Register

PS099782

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel