Pink Sheet is part of the Informa Intelligence Division 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

Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft

This article was originally published in The Tan Sheet

Executive Summary

FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance.

Advertisement

Related Content

RAPS Annual Conference In Brief
FDA Supplement Enforcement Priorities Go Beyond NDI Notification
FDA Oversteps Its Bounds In Guidance On Research-Only Tests, Firms Say
FDA Guidance Policy Could Be Hurt By Ruling On Animal Drug Compounding
FDA NDI Notification Draft Guidance Contradicts Final Rule – Ullman
In Brief
GMP Cost Impact, Ephedra Suits Loom Over Supplement Industry – Israelsen
Dietary Supplement Reps Ask FDA For Clarity Across The Board On NDIs

Topics

Advertisement
UsernamePublicRestriction

Register

PS105540

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