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

OTC Adverse Event Draft Guidance Addresses Multi-Product Reporting

This article was originally published in The Tan Sheet

Executive Summary

Over-the-counter drug companies need only submit one safety report when a serious adverse event involves multiple drugs, according to FDA's draft guidance on adverse event reporting and recordkeeping for nonprescription drugs

You may also be interested in...



Supplement AER Draft Guidance Omits Answers, But Recognizes Complexities

FDA's draft guidance for dietary supplement adverse event reports encourages firms to employ health care professionals to take information from consumers and other sources of adverse event calls

Adverse Event System Success Will Depend On Trained Reporters, Experts Say

Training potential reporters of adverse events may be crucial to the effectiveness of a mandatory adverse event reporting system, industry stakeholders say

Avoiding GMP “Showstoppers” Keeps Manufacturers Off FDA’s “Radar”

Compliance consultants warn that certain dietary supplement good manufacturing practices violations are inspection "showstoppers" and will draw agency enforcement

Topics

UsernamePublicRestriction

Register

PS101002

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