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


Expedited drug review procedures final rule

Executive Summary

Due imminently based on FDA's projected regulatory agenda. In keeping with the agenda's usual optimism, FDA, in the Oct. 29 Federal Register, provided Oct. 31 as the date for publication of the final rule for expedited review of drugs for treating life-threatening/debilitating illnesses. The agenda also indicated that the interim final rule for retention of drug samples used in bioequivalence or bioavailability studies will issue in the near future. Final action is expected in May for an amendment to the IND regs that would include reasons for ceasing distribution of an experimental drug under a parallel track mechanism. According to the agenda, FDA expects to issue in March the final rule for food labeling regulations that will allow use of certain health messages.



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