Promotion of FDA-Regulated Medical Products 4
take enforcement actions if they do not comply with
applicable regulations. FDA has many tools to compel
compliance, including:
• Form 483—an official document an FDA
investigator uses to record any observations of
regulatory violations after an inspection
• Warning and Untitled Letters—written
warnings that a company is in violation of
an applicable regulation (or regulations) and
demanding corrective actions to address the
violation(s)
• Regulatory Meeting—a meeting with FDA
officials to discuss how a company intends to
resolve inspectional observations that have not
been addressed to the agency’s satisfaction
• Product Seizure—confiscation of finished
product intended for sale that FDA has identi-
fied as a potential public health hazard
Sidebar 1-1. FDA Regulatory Basics
Federal Register Notices
When new guidance documents, regulations or other notices are issued
by FDA, they are published as Federal Register notices. The Federal
Register is the official daily publication of the US government and can
provide additional useful perspective on FDA policy. Federal Register
notices are cited in this book as “[volume] FR [page number] ([date]).”
Notices of Violation (NOV)
or Warning Letters
FDA sends a Notice of Violation
(NOV) letter (also called an
Untitled Letter) or a Warning
Letter to a company when it
believes a company’s actions
have violated the law. All OPDP/
Division of Drug Marketing,
Advertising and Communications
(DDMAC) enforcement letters
issued since 1997 are posted
publicly on the agency website.
FD&C Act
This law is relevant to FDA’s oversight of prescription drug promotion,
and was enacted in 1938. The FD&C Act was recently amended by
the Food and Drug Administration Amendments Act of 2007 (FDAAA),
the Food and Drug Administration Safety and Innovation Act of 2012
(FDASIA), the 21st Century Cures Act of 2016 (Cures Act) and the Food
and Drug Administration Reauthorization Act of 2017 (FDARA).
Guidance Documents
FDA issues guidance documents
that provide useful insight into
the agency’s interpretation of its
own regulations and often are
followed by companies as though
they have the force of law. Unlike
laws or regulations, however,
guidance documents are not
legally binding on FDA or industry.
Code of Federal Regulations (CFR)
When implementing laws, FDA can
interpret the laws into more detailed
regulations. The primary regulations
regarding prescription drug labeling
and promotion are codified at
21 CFR 201 and 21 CFR 202.
US Code (USC)
USC is a compilation of all US federal laws. This includes Title 21,
which contains the FD&C Act and laws relating to food and drugs.
take enforcement actions if they do not comply with
applicable regulations. FDA has many tools to compel
compliance, including:
• Form 483—an official document an FDA
investigator uses to record any observations of
regulatory violations after an inspection
• Warning and Untitled Letters—written
warnings that a company is in violation of
an applicable regulation (or regulations) and
demanding corrective actions to address the
violation(s)
• Regulatory Meeting—a meeting with FDA
officials to discuss how a company intends to
resolve inspectional observations that have not
been addressed to the agency’s satisfaction
• Product Seizure—confiscation of finished
product intended for sale that FDA has identi-
fied as a potential public health hazard
Sidebar 1-1. FDA Regulatory Basics
Federal Register Notices
When new guidance documents, regulations or other notices are issued
by FDA, they are published as Federal Register notices. The Federal
Register is the official daily publication of the US government and can
provide additional useful perspective on FDA policy. Federal Register
notices are cited in this book as “[volume] FR [page number] ([date]).”
Notices of Violation (NOV)
or Warning Letters
FDA sends a Notice of Violation
(NOV) letter (also called an
Untitled Letter) or a Warning
Letter to a company when it
believes a company’s actions
have violated the law. All OPDP/
Division of Drug Marketing,
Advertising and Communications
(DDMAC) enforcement letters
issued since 1997 are posted
publicly on the agency website.
FD&C Act
This law is relevant to FDA’s oversight of prescription drug promotion,
and was enacted in 1938. The FD&C Act was recently amended by
the Food and Drug Administration Amendments Act of 2007 (FDAAA),
the Food and Drug Administration Safety and Innovation Act of 2012
(FDASIA), the 21st Century Cures Act of 2016 (Cures Act) and the Food
and Drug Administration Reauthorization Act of 2017 (FDARA).
Guidance Documents
FDA issues guidance documents
that provide useful insight into
the agency’s interpretation of its
own regulations and often are
followed by companies as though
they have the force of law. Unlike
laws or regulations, however,
guidance documents are not
legally binding on FDA or industry.
Code of Federal Regulations (CFR)
When implementing laws, FDA can
interpret the laws into more detailed
regulations. The primary regulations
regarding prescription drug labeling
and promotion are codified at
21 CFR 201 and 21 CFR 202.
US Code (USC)
USC is a compilation of all US federal laws. This includes Title 21,
which contains the FD&C Act and laws relating to food and drugs.