Assignment Background
Per the FDA’s Regulatory Procedures Manual (December 2017) Chapter 4, Advisory Actions:
04 RPM Chapter 20171207 draft clean 508 R2
A Warning Letter is a correspondence that notifies the regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.
Lomaira Warning Letter
An Untitled Letter is an initial correspondence with a regulated industry that cites violations that do not meet the threshold of a Warning Letter. Untitled Letters are intended to cover those circumstances where the Agency has a need to communicate with regulated industry about violations that do not meet the threshold of regulatory significance as described above. The three types of letters related to licensed products that are issued by CBER and CDER, pursuant to subsection 6.3 of Exhibit 4-1 do not necessarily fall within this definition of an Untitled Letter; however, they are still Untitled Letters that are covered by the scope of these procedures.
Xtampza ER Letter
III. Assignment
In February 2017 the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an Untitled Letter to Collegium Pharmaceutical, Inc. for violating the FD&C Act.
In December 2017 the OPDP issued a Warning Letter to AVANTI, INC. for violating the FD&C Act.
1. Please describe in detail what a Warning Letter is and what FDA uses Warning Letters for, and describe the differences between an Untitled Letter and Warning Letter.
2. Review the letters sent to Collegium and Avanthi, and explain the FDA’s reasoning for issuing an Untitled Letter to Collegium vs. a Warning Letter to Avanthi.
3. Once you have provided the FDA’s rationale, please describe whether you agree with their approach and why.
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