Promotion of FDA-Regulated Medical Products 5
• Preventing Review or Approval of Pending
Product Applications—an administrative hold
FDA places on all pending and future drug
and device premarket submissions until all
regulatory violations are resolved
• Injunction—a judicial order FDA obtains
to shutter a manufacturing facility due to
serious regulatory violations that would likely
threaten public health
• Blocking Imports—an order FDA issues
detaining drugs and devices intended for
import at the US border or ports of entry
• Civil and Criminal Charges—FDA referral
of companies accused of serious regulatory
violations to the US Department of Justice for
civil or criminal prosecution
Besides rule-making and performing regulatory
inspections, FDA ensures prescription drugs, biolog-
ics and Class II and III medical devices’ safety and
effectiveness by requiring companies to submit exten-
sive applications for review by FDA scientists prior to
commercialization. If FDA approves the application, a
medical product may be sold in the US however, FDA
can impose special postmarket conditions to mitigate
excessive risk. For prescription drugs and therapeutic
biologics, FDA requires submission of proposed
indications for use, labels and labeling as part of a new
drug application (NDA) or biologics license application
(BLA). Manufacturers must submit all promotional
labeling for prescription drugs and therapeutic biologics
for review prior to publication or dissemination. FDA’s
regulatory oversight of prescription drug and biologics
promotional materials disseminated to medical profes-
sionals and patients allows significant agency control
over claims of safety and effectiveness. However, device
manufacturers are not required to submit promotional
labeling for FDA review at any time.
FDA’s Office of Medical Products and Tobacco
is subdivided into specialized centers and offices that
focus on specific medical product categories (see Figure
1-1), and specific subdivisions are responsible for
reviewing promotional materials for drugs, biologics
and devices.
FDA Offices Dealing With Product
Labeling
Office of Prescription Drug Promotion (OPDP)
FDA monitors the promotion of prescription drugs and
therapeutic biologics through its Office of Prescription
Drug Promotion (OPDP). OPDP is part of the Office
Figure 1-1. Organization Chart of FDA’s Office of Medical Products and Tobacco
Office of Special Medical Programs
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Tobacco Products
Office of the Commissioner
Office of Medical Products and Tobacco
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
• Preventing Review or Approval of Pending
Product Applications—an administrative hold
FDA places on all pending and future drug
and device premarket submissions until all
regulatory violations are resolved
• Injunction—a judicial order FDA obtains
to shutter a manufacturing facility due to
serious regulatory violations that would likely
threaten public health
• Blocking Imports—an order FDA issues
detaining drugs and devices intended for
import at the US border or ports of entry
• Civil and Criminal Charges—FDA referral
of companies accused of serious regulatory
violations to the US Department of Justice for
civil or criminal prosecution
Besides rule-making and performing regulatory
inspections, FDA ensures prescription drugs, biolog-
ics and Class II and III medical devices’ safety and
effectiveness by requiring companies to submit exten-
sive applications for review by FDA scientists prior to
commercialization. If FDA approves the application, a
medical product may be sold in the US however, FDA
can impose special postmarket conditions to mitigate
excessive risk. For prescription drugs and therapeutic
biologics, FDA requires submission of proposed
indications for use, labels and labeling as part of a new
drug application (NDA) or biologics license application
(BLA). Manufacturers must submit all promotional
labeling for prescription drugs and therapeutic biologics
for review prior to publication or dissemination. FDA’s
regulatory oversight of prescription drug and biologics
promotional materials disseminated to medical profes-
sionals and patients allows significant agency control
over claims of safety and effectiveness. However, device
manufacturers are not required to submit promotional
labeling for FDA review at any time.
FDA’s Office of Medical Products and Tobacco
is subdivided into specialized centers and offices that
focus on specific medical product categories (see Figure
1-1), and specific subdivisions are responsible for
reviewing promotional materials for drugs, biologics
and devices.
FDA Offices Dealing With Product
Labeling
Office of Prescription Drug Promotion (OPDP)
FDA monitors the promotion of prescription drugs and
therapeutic biologics through its Office of Prescription
Drug Promotion (OPDP). OPDP is part of the Office
Figure 1-1. Organization Chart of FDA’s Office of Medical Products and Tobacco
Office of Special Medical Programs
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Tobacco Products
Office of the Commissioner
Office of Medical Products and Tobacco
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6