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

Supplement AER guidance questioned

This article was originally published in The Tan Sheet

Executive Summary

FDA should define more clearly elements of its serious adverse event report guidance for dietary supplements, a food and drug attorney says. A. Wes Siegner, of Hyman, Phelps & McNamara in Washington, tells FDA his client Nutraceutical Corp. is concerned about the agency's recommendation that a person responsible for submitting AERs use "diligent efforts" to obtain data from a patient or reporter. Siegner's Nov. 23 1letter says, "If FDA intends to equate 'diligent efforts' with the use of health care practitioners or other methods to elicit the minimum data elements, FDA should" state its expectations. Siegner also takes issue with the agency's definitions of "identifiable patient," "initial reporter" and "serious" AERs in the June 2009 2guidance (3"The Tan Sheet" July 20, 2009)

You may also be interested in...



Final Guidance For Reporting Adverse Events Gets Serious On Definitions

A report of emergency room treatment connected to use of a dietary supplement may not connote a serious adverse event, FDA says in the final guidance on the reporting and recordkeeping of AE information for supplements

Akorn Defaults On Loan Agreement After Sale Bid Falls Flat

Facing soaring legal costs stemming from its failed merger with Fresenius Kabi and burdened by substantial debt, Akorn elected to put itself up for sale earlier this year in order to help repay lenders. But the company has now defaulted on an agreement with its creditors after no bidder stepped up to the plate.

Pipeline Watch: Vericiguat, Evinacumab Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Topics

UsernamePublicRestriction

Register

PS103581

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