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

UsernamePublicRestriction

Drug Firms Have More Time For First Annual Report On Production Volumes US Is Requiring

Executive Summary

FDA announces day before due date that as it continues considering comments to a draft guidance on the requirement it published in October, the “document is not a binding document” and “the recommended … reporting date for 2020 data is not a requirement.”

You may also be interested in...



Annual Report With Monthly Production Totals Added To OTC Monograph Drug Firms' To-Do List

Firms making drugs available in US without pre-market approval, including homeopathics, got another annual reporting requirement under CARES Act.  “It's going to be a bit of a sea change for the industry, and they're going to need to be prepared for it,” says attorney Ann Begley.

How US FDA Wants Pharmaceutical Production Volumes Reported For Drug Shortage Prevention

Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.

US OTC Monograph FY2022 Facility Fees Deadline In June At Amount TBD

Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS152211

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

Cancel