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

FDA Prepares To Begin Search For Safety Issues At Molecular Level

Executive Summary

FDA is exploring a pharmacological approach for identifying a drug's safety characteristics so sponsors can assess risk earlier in the drug development process

You may also be interested in...



Genomic Data Collection Encouraged, But Not Mandated, For Early Clinical Studies

FDA draft guidance emphasizes importance of pre-specifying DNA sample collection at the start of a clinical program.

FDA Should Ease Criteria For Some Renal Studies, Advisory Cmte. Says

FDA should amend its new renal testing guidance to reflect real-world conditions and ease the burden - in at least one area - for sponsors, according to an FDA advisory committee. With an eye toward facilitating clinical testing, the panel recommended that the agency change its patient selection criteria for one segment of pharmacokinetics studies on the effect of renal impairment on drug dosing

FDA Should Ease Criteria For Some Renal Studies, Advisory Cmte. Says

FDA should amend its new renal testing guidance to reflect real-world conditions and ease the burden - in at least one area - for sponsors, according to an FDA advisory committee. With an eye toward facilitating clinical testing, the panel recommended that the agency change its patient selection criteria for one segment of pharmacokinetics studies on the effect of renal impairment on drug dosing

Topics

UsernamePublicRestriction

Register

ID1131516

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