Pink Sheet 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

FDA's NEW ADVERSE DRUG REACTION PROCESSING PROCEDURES

Executive Summary

FDA's NEW ADVERSE DRUG REACTION PROCESSING PROCEDURES give the agency on-line retrieval capacity for aggregate analysis of adverse drug reaction (ADR) reports, FDAer Wayne Turner, Office of Epidemiology & Biometrics, told a Drug Information Assn. workshop held in Washington, D.C. Oct. 18-20.Turner said the agency's aim "is to have all newly received reports accessible for on-line retrieval within one week after receipt." As part of FDA's effort to improve the processing of ADR reports, Turner noted that the Div. of Drug & Biologic Product Experience was reorganized and a new branch, the Adverse Reaction & Poisoning Surveillance Branch, created. The technical processing of ADR reports is now conducted by the adverse reaction section of the new branch rather than the Reports & Evaluation Branch. Turner explained that under the new procedure, ADR reports are mailed to the adverse reaction section, which forwards the reports to the reports evaluation branch for costarting assignment of FDA terminology for adverse reaction information). The reports are then returned to the adverse reaction section where they are keypunched into the data entry system in an unevaluated form."The day after the unevaluated reports are entered into the computer, the raw data are retrievable from the on-line system," Turner said. Turner added that mfr. 15-day reports and reports received directly from practitioners are returned to the reports evaluation branch for assessment of the presence of the reaction in current labeling, causality, severity and adequacy of the report. He said mfr. periodic reports will skip the evaluation process. The quality is reviewed and they are sent to update the master file. The FDAer also noted the agency's desire for mfrs. to submit ADR information on computer tapes. "We are formally announcing our desire and preparation to receive costarted adverse reaction data on computer tape." He pointed out that 15 day reports should not be submitted on tape. Turner said specifications for submitting and entering adverse reaction information into FDA's computer system have already been distributed to some companies who have expressed interest in computer tape submission.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS007386

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