 |
Untitled Page
Untitled Page
|
|
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 18-662/S-056
Hoffman La-Roche
Attention: Ellen Carey, Senior Program Manager
340 Kingsland Street
Nutley, New Jersey 07110-1199
Dear Ms Carey:
Please refer to your pending supplemental new drug application
submitted June 24, 2005, received June 27, 2005 under
section 505(b) of the Federal Food, Drug, and Cosmetic
Act for Accutane (isotretinoin) Capsules, 10 mg, 20
mg, and 40 mg.
We acknowledge receipt of your submissions dated July
1, July 14, July 21, July 26, July 28, July 29, August
2, August 3, August 5, August 9, and August 11, 2005.
This supplemental application, considered for approval
under 21 CFR 314.520 (Subpart H), at your request because
of the teratogenicity of isotretinoin, proposes the
iPLEDGE program, an enhanced risk minimization action
plan (RiskMAP) designed to minimize drug exposure during
pregnancy.
We have completed the review of this supplemental application,
as amended, and have concluded that adequate information
has been presented to approve the supplemental application
for Accutane (isotretinoin) Capsules, 10mg, 20mg, and
40mg. You have indicated your agreement with approval
under 21 CFR 314.520 (Subpart H). Accordingly, this
supplemental application is approved under 21CFR 314.520
(Subpart H). Approval is effective on the date of this
letter for use as recommended in the agreed upon labeling
and the components of the iPLEDGE RiskMAP.
Accutane RiskMAP
We remind you that your Accutane RiskMAP (called iPLEDGE)
is an important part of the
postmarketing risk management for Accutane, and must
include each of the following components:
1. Registration in the iPLEDGE program of wholesalers,
prescribers, pharmacies, and patients who agree to accept
specific responsibilities in order to distribute, prescribe,
dispense, and use Accutane.
2. Implementation of a program and distribution of materials
to educate wholesalers, prescribers, pharmacists, and
patients about the risks and benefits of Accutane.
3. Implementation of a reporting and data collection
system for: 1) serious adverse events
associated with the use of Accutane that complies with
the reporting requirements for an
approved NDA (21 CFR 314.80 and 314.81) and 2) sales
and dispensing of Accutane outside
of the iPLEDGE program.
4. Implementation of a plan to monitor, evaluate, and
improve minimization of drug exposure during pregnancy
and compliance with restrictions for safe use under
the iPLEDGE program. A component of the evaluation program
includes a pregnancy registry to elucidate the root
cause of potential RiskMAP failure.
The iPLEDGE program, as described in the attached documents,
adequately addresses each of these requirements. Any
change to the program must be discussed with FDA prior
to its institution and is subject to FDA’s determination
that the required components continue to be met. We
expect your continued cooperation to resolve any problems
regarding the iPLEDGE program that may be identified
following approval of this supplement.
We remind you of your specific reporting obligations
regarding serious adverse events in patients who have
received Accutane. As set forth in the attached document,
in addition to the usual postmarketing reporting of
adverse drug experiences (21 CFR 314.80(c)), you will
submit a 15-day report for each of the following:
• All pregnancy exposures to Accutane; and
• All psychiatric events including suicides, attempted
suicides, and suicidal ideation
Within the first year of initiation of the iPLEDGE program,
and at the specified time frames thereafter, in addition
to the Periodic Adverse Drug Experience Report required
under 21 CFR 314.80(c), you must provide FDA with the
following reports that will evaluate the success of
the program in achieving program goals and compliance
with program restrictions and requirements.
1. Special Pregnancy Periodic Quarterly Report: A quarterly
report that provides information on U.S. maternal and
fetal exposures to Accutane.
2. iPLEDGE Program Evaluation Report: A quarterly report
that includes evaluation of program components and the
rate of compliance with each in accordance with the
Process Compliance Evaluation Plan discussed below,
including sponsor adherence to restrictions of drug
distribution to registered wholesalers, oversight of
wholesaler, prescriber, pharmacy and patient compliance
with relevant program requirements, and oversight of
the iPLEDGE data base.
3. Non-Compliant Distribution Reports: Special reports
submitted to the Division of Compliance Risk Management
and Surveillance for each known occurrence during the
interval since the last Program Evaluation report of:
a) sale of any Accutane product by a wholesaler to an
unregistered and/or un-activated pharmacy or unregistered
wholesaler, b) dispensing of any Accutane product by
an unregistered and/or un-activated pharmacy, and c)
corrective action taken by Hoffman La-Roche for each
occurrence under a) and b). These reports will be submitted
within 15 days of the sponsor’s receipt of new
information to the following address:
Division of Compliance Risk Management and Surveillance
(HFD-330)
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
The content of the reports, objectives and plans for
evaluation, and correction of noncompliant behavior
are further described in the attached “Accutane
Risk Minimization Action Plan: Summary of iPLEDGE”.
To further assist FDA in evaluating any reported adverse
events associated with the use of Accutane and to assist
FDA in evaluating the success of the iPLEDGE program
in preventing exposure of the drug in pregnant women,
the Annual Periodic Adverse Drug Experience Report [required
under 314.80(c)(2)], the Psychiatric Quarterly Report,
the Special Pregnancy Report, and the iPLEDGE Program
Evaluation Report will be submitted on the harmonized
schedule below. The harmonized time frames are based
on the date of mandatory compliance with the iPLEDGE
program, December 31, 2005. It is understood that the
initial reports may not represent a full calendar quarter
or year, as appropriate. The following chart provides
the harmonized specific quarterly and annual time
periods for these reports:
Reporting Period: Quarterly Reports
Quarter 1: January 1 – March 31 (the first report
for 2006 will cover December 31, 2005 – March
31, 2006)
Quarter 2: April 1 – June 30
Quarter 3: July 1 – September 30
Quarter 4: October 1 – December 31
Reporting Period: Annual Reports
January 1 – December 31 (the first report will
cover December 31, 2005 through December 31, 2006)
In addition, a “close-out” Annual Periodic
Adverse Drug Experience Report, Special Pregnancy Report,
and Program Evaluation Report will be submitted that
covers the time period from the last report through
December 30, 2005. Submit the Annual Periodic Adverse
Drug Experience Report, the Psychiatric Quarterly Report,
the Special Pregnancy Report, and the iPLEDGE Program
Evaluation Report, including the “close-out”
reports, to the Division of Dermatologic and Dental
Drug Products and three copies of all the reports directly
to:
Office of Drug Safety (HFD-400)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
FDA will re-evaluate the adequacy of the iPLEDGE program
on a continuing basis regarding its success in achieving
the goal of minimizing drug exposure during pregnancy
and adherence to program components. Failure of iPLEDGE
to achieve minimization of drug exposure during pregnancy,
or failure to adhere to program components that may
lead to pregnancy exposures, could lead to further regulatory
action.
We agree that by November 12, 2005, Hoffman La-Roche
will submit a Process Compliance
Evaluation Plan designed to monitor, detect, and correct
distribution outside the iPLEDGE program. FDA and Hoffman
La-Roche have agreed that the Process Compliance Evaluation
Plan will include the elements described in your submission
of August 11, 2005, entitled “Agreements Needed
for Compliance Evaluation Plan.” The agreed upon
plan will be implemented by January 1, 2006.
Pursuant to 21 CFR Part 208, FDA has determined that
Accutane poses a serious and significant public health
concern requiring distribution of a Medication Guide.
The Medication Guide is necessary for patients’
safe and effective use of Accutane. FDA has determined
that Accutane is a product that has serious risks of
which patients should be made aware because information
concerning the risks could affect patients’ decisions
to use Accutane. In addition, patient labeling could
help prevent serious adverse events related to use of
the product.
The final printed labeling (FPL) must be identical to
the enclosed agreed upon labeling text submitted August
11, 2005 for the Package Insert, Patient Information/Informed
Consents, and Medication Guide and for the blister card
and carton labels. Marketing the product with FPL with
text that is not identical to the approved text may
render the product misbranded and an unapproved new
drug.
Please submit 20 paper copies of the FPL as soon as
it is available, in no case more than 30 days after
it is printed. Please individually mount ten of the
copies on heavy-weight paper or similar material. Alternatively,
you may submit the FPL electronically according to the
guidance for industry titled Providing Regulatory Submission
in Electronic Format - NDAs (January 1999). For administrative
purposes, this submission should be designated “FPL
for approved supplement NDA 18-662/S-056.” Approval
of this submission by FDA is not required before the
labeling is used.
Under 21 CFR 314.550, after the initial 120 day period
following this approval, you must submit all promotional
materials, including promotional labeling as well as
advertisements, at least 30 days prior to the intended
time of initial dissemination of the labeling or initial
publication of the advertisement. Submit all proposed
materials in draft or mock up form, not final print.
Send one copy to the Division of Dermatologic and Dental
Drug Products and two copies of both the promotional
materials and the labeling directly to:
Division of Drug Marketing, Advertising, and Communications
(HFD-42)
Center for Drug Evaluation and Research
Food Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
If you have any questions, please call Kalyani Bhatt,
Regulatory Project Manager, at (301) 827-2020.
Sincerely,
Florence Houn, MD
Director
Office of Drug Evaluation III
Center for Drug Evaluation and Research
ACCUTANE RISK MINIMIZATION ACTION
PLAN: SUMMARY of iPLEDGE
iPLEDGE is a performance-linked access system that,
for female patients of childbearing potential, ties
pregnancy testing results and Accutane prescription
and dispensing. The iPLEDGE program is a computer-based
Risk Minimization Action Plan (RiskMAP) that involves
registration of wholesalers and registration and activation
of pharmacies, prescribers, and patients to control
distribution, dispensing, prescribing, and access to
Accutane.
I. Prescribing Program
A. General requirements: Hoffman La-Roche will ensure
that the following requirements are
addressed by its RiskMAP, iPLEDGE:
1. Accutane must only be distributed by iPLEDGE registered
wholesalers, dispensed by
iPLEDGE registered and activated pharmacies, prescribed
by iPLEDGE registered and
activated prescribers, and prescribed/dispensed for
iPLEDGE registered and activated
patients. Wholesalers, prescribers, pharmacies, and
patients may voluntarily terminate
registration or deactivate from the iPLEDGE program
at any time. Hoffman La-Roche may
remove from the iPLEDGE program registered wholesalers
and activated pharmacies and
activated prescribers if agreed upon responsibilities
are not met.
2. For females of childbearing potential, Accutane must
only be prescribed initially on
confirmation of two negative pregnancy tests (one screening
test conducted when the
decision is made to pursue qualification of the patient
for Accutane and a second
confirmation test conducted at a CLIA-certified laboratory
within seven days of the office
visit). Subsequent prescriptions are contingent on confirmation
of a monthly negative
pregnancy test conducted at a CLIA-certified laboratory.
B. Wholesaler registration: Hoffman la-Roche will accept
registrations for iPLEDGE from
wholesalers who agree to the following:
1. To register prior to distributing Accutane and re-register
annually thereafter.
2. To distribute only FDA-approved Accutane product.
3. To only ship Accutane to wholesalers registered in
the iPLEDGE program with prior
written consent from Hoffman La-Roche or pharmacies
licensed in the U.S. and registered
and activated in the iPLEDGE program.
4. To notify Hoffman La-Roche (or delegate) of any non-registered
and/or non-activated
pharmacy or unregistered wholesaler that attempts to
order Accutane.
5. To comply with inspection of wholesaler records for
verification of compliance with the
iPLEDGE program by Hoffman La-Roche (or delegate).
6. To return to the Hoffman La-Roche (or delegate) any
undistributed product if registration is
revoked by Hoffman La-Roche or if the wholesaler chooses
to not reregister annually.
7. To provide product flow data to Hoffman La-Roche
(or delegate) as detailed in the
wholesalers agreement.
C. Pharmacy registration and activation:
1. Hoffman La-Roche will accept registration for and
activate into iPLEDGE only pharmacies
that, through the designated Responsible Site Pharmacist
(RSP), agree to the following:
a. To attest to knowing the risk and severity of fetal
injury/birth defects from Accutane.
b. To train all pharmacists, who participate in the
filling and dispensing of Accutane
prescriptions, on the iPLEDGE program requirements.
c. To comply with the iPLEDGE program requirements,
and seek to ensure all
pharmacists who participate in the filling and dispensing
of Accutane prescriptions
comply with the iPLEDGE program requirements.
d. To obtain Accutane product only from iPLEDGE registered
wholesalers.
e. To not sell, borrow, loan, or otherwise transfer
Accutane in any manner to or from
another pharmacy.
f. To return to Hoffman La-Roche (or delegate) any unused
product if registration is
revoked by Hoffman La-Roche or if the pharmacy chooses
to not reactivate annually.
g. To not fill Accutane for any party other than a qualified
patient.
h. To dispense only FDA-approved Accutane products
i. To not dispense or otherwise obtain Accutane product
through the internet or any other
means outside of the iPLEDGE program.
j. To re-activate annually
2. Hoffman La-Roche will only accept registration for
and activation into iPLEDGE,
pharmacies whose pharmacists that will dispense Accutane,
agree to the following:
a. To be trained by the RSP concerning the iPLEDGE program
requirements.
b. To obtain authorization from the iPLEDGE program
via the internet or telephone for
every Accutane prescription.
c. To write the risk Management Authorization (RMA)
number on the prescription.
d. To comply with iPLEDGE dispensing requirements.
i Dispense in no more than a 30-day supply.
ii Dispense with an Accutane Medication Guide
iii Dispense only after authorization from the iPLEDGE
program.
iv Dispense prior to the “do not dispense to a
patient after” date provided by the
iPLEDGE system.
v Dispense only with a new prescription for refills
and another authorization from the
iPLEDGE program.
D. Prescriber registration and activation:
1. Hoffman La-Roche will accept registration for and
activation into iPLEDGE only
prescribers who agree to activate their registration,
and reactivate annually thereafter by
attesting to the following:
a. To possess specified skills and knowledge
b. To comply with iPLEDGE program requirements.
c. To counsel female patients of childbearing potential
before beginning Accutane therapy
and on a monthly basis, to avoid pregnancy by using
two forms of contraception
simultaneously and continuously one month before, during,
and one month after
Accutane therapy, unless the patient commits to continuous
abstinence.
d. To not prescribe Accutane to any female patient of
childbearing potential until verifying
that she has a negative screening pregnancy test and
monthly negative CLIA-certified
pregnancy tests as well as at the completion of therapy
and one month later.
e. To report any pregnancy case that occurs while a
female patient is on Accutane and for
one month after the last dose to the pregnancy registry.
f. To obtain the patient’s signed informed consent
prior to prescribing Accutane.
2. Hoffman La-Roche will accept registration for and
activation into iPLEDGE only
prescribers who agree to access the iPLEDGE system via
the internet or telephone to:
a. Register each patient in the iPLEDGE program.
b. Confirm monthly that each patient has received counseling
and education.
c. For female patients of childbearing potential:
i Enter the patient’s two chosen forms of contraception
each month.
ii Enter monthly results from CLIA-certified laboratory
conducted pregnancy test.
d. Ensure that all patients, and specifically female
patients of childbearing potential, meet
the requirements to be registered and activated in the
iPLEDGE program.
The tasks of counseling patients, obtaining informed
consent, and obtaining and inputting
patient registration information, pregnancy test results,
and reported adverse events (including pregnancy exposures)
may be delegated to qualified staff.
E. Patient registration and activation: Hoffman La-Roche
will accept registration for and activation
into iPLEDGE only patients who meet the following conditions:
1. Must be registered with the iPLEDGE program by the
prescriber.
2. Must understand that severe birth defects can occur
with the use of Accutane by female
patients.
3. Must be reliable in understanding and carrying out
instructions.
4. Must sign a “Patient Information/Informed Consent
(for all patients)” form that contains
warnings about the potential risks associated with Accutane.
5. Must fill the prescription within seven days of the
office visit.
6. Must not donate blood while on Accutane and for one
month after therapy has ended.
7. Must not share Accutane with anyone.
In addition to the requirements for all patients described
above, female patients of childbearing
potential must meet the following conditions:
1. Must not be pregnant or breast-feeding.
2. Must comply with the required pregnancy testing at
a CLIA-certified laboratory.
3. Must be capable of complying with the mandatory contraceptive
measures for Accutane
therapy, or commit to continuous abstinence from heterosexual
intercourse, and understand
behaviors associated with an increased risk of pregnancy.
4. Must understand the responsibility to avoid pregnancy
one month before, during, and one
month after Accutane therapy.
5. Must sign an additional “Patient Information/Informed
Consent About Birth Defects (for
female patients who can get pregnant)” form, before
starting Accutane therapy.
6. Must access the iPLEDGE program via the internet
or telephone before starting Accutane,
on a monthly basis during therapy, and one month after
the last dose to answer questions on the program requirements
and to enter their two chosen forms of contraception.
7. Must understand the purpose and importance of providing
information to the iPLEDGE
program should pregnancy occur while taking Accutane
or within one month of the last
dose.
II. Educational program: Hoffman La-Roche will implement
an educational program for wholesalers, pharmacies,
prescribers, and patients regarding the risks and benefits
associated with the use of Accutane, education for contraception
compliance, the requirements of the iPLEDGE program,
and the requirements for interactions with the iPLEDGE
program. Materials and proposals that address these
educational requirements were submitted August 11, 2005
and include the following:
A. Prescriber Educational Materials
1. The iPLEDGE Program: Guide to Best Practices for
Isotretinoin.
2. Prescribing Checklist: First Office Visits for Females
of Childbearing Potential.
3. Prescribing Checklist: First Office Visits for Males
and Females Who Cannot Get Pregnant.
4. The iPLEDGE Program Contraception Referral Form and
Contraception Counseling Guide.
5. The iPLEDGE Program: Prescriber Contraception Counseling
Guide.
6. Recognizing Psychiatric disorders in Adolescents
and Young Adults: A Guide for
Prescribers of Isotretinoin.
B. Pharmacy Educational Materials
1. The iPLEDGE Program: Pharmacist Guide for Isotretinoin
C. Patient Educational Materials
1. The iPledge Program: Patient Introductory Brochure
2. The iPLEDGE Program: Guide to Isotretinoin for Male
Patients and Female Patients Who
Cannot Get Pregnant
3. The iPLEDGE Program: Guide to Isotretinoin for Female
Patients Who Can Get Pregnant:
The Importance of Avoiding Pregnancy on Isotretinoin
4. The iPLEDGE Program: Birth Control Workbook
D. Additional Information Sources:
1. iPLEDGE Information Internet Web Page
2. Call Center Support: A call center will be maintained
to respond to healthcare practitioner, patient, pharmacist,
and wholesaler questions and requests for information.
III. Reporting: Hoffman La-Roche will implement a reporting
and collection system for:
1) serious adverse events associated with the use of
Accutane that complies with the reporting requirements
for an approved NDA (21 CFR 314.80 and 314.81) and 2)
for sales and dispensing of drug outside the iPLEDGE
program. Reports will include the following:
A. 15-Day Adverse Event Reports: In addition to the
postmarketing adverse events that meet the requirements
for reporting under 21 CFR 314.80(c), the following
will be reported as 15-Day Adverse Drug Experience Report:
1. All pregnancy exposures.
2. All psychiatric adverse events including suicides,
attempted suicides, and suicidal ideation.
B. Periodic Adverse Drug Experience Report
1. Narrative summary and analysis of information in
the report.
2. Analysis by system organ class of the 15-Day Adverse
Event Reports submitted in the
preceding year.
3. Reports of adverse events not previously submitted
as 15-Day Adverse Event Reports.
4. A history of action taken due to the occurrence of
adverse events since the previous
Periodic Adverse Drug Experience Report.
C. Psychiatric Quarterly Report: All psychiatric adverse
events associated with the use of
isotretinoin will be submitted quarterly as a supplementary
report to the Periodic Adverse Drug Experience Report.
D. Special Pregnancy Quarterly Report: The following
data will be submitted as a supplementary report to
the Periodic Adverse Drug Experience Report.
a. All pregnancy exposures to Accutane in the U.S.
b. All cases of fetal malformation resulting from pregnancy
exposure to Accutane in the
U.S.
c. Copies of all 15-Day Adverse Event Reports for cases
of pregnancy exposure to
Accutane in the U.S. and fetal malformation resulting
from Accutane exposure in the
U.S.
E. Non-Compliant Distribution Reports: A description
of all instances of sales and dispensing of Accutane
product outside of the iPLEDGE program will be submitted
within 15 days of
Hoffman La-Roche’s receipt of new information.
Reports will include the following:
1. Information on the sale of any Accutane product by
a wholesaler to an unregistered and/or un-activated
pharmacy or unregistered wholesaler.
2. Information on dispensing of any Accutane product
by an unregistered and/or un-activated pharmacy.
3. The details of the information to be submitted and
the content, format, and frequency of the report will
be agreed to by FDA.
IV. iPLEDGE Program Evaluation: Hoffman La-Roche, or
their delegate, will conduct an evaluation of the effectiveness
of the iPLEDGE program in minimizing drug exposure during
pregnancy. The evaluation program will include the following:
A. Pregnancy Registry: Hoffman La-Roche will establish
a pregnancy registry to actively collect information
on any pregnancies occurring in female patients treated
with Accutane. Paternal (exposed and non-exposed) cases
will be excluded from the registry. The content, format,
and frequency of reporting will be agreed to by FDA.
The registry will be designed to incorporate the following:
1. Objectives
a. Determine Accutane exposure status for each reported
pregnancy.
b. Document the outcome of each Accutane exposed pregnancy.
c. Provide pregnancy documentation to assist in the
evaluation, by root cause analysis, of
iPLEDGE failures of each exposed pregnancy.
d. Provide pregnancy data in periodic reports to FDA.
2. Outcome measures
a. Pregnancy outcome.
b. Congenital anomalies (major and minor birth defects).
c. Other pregnancy or delivery complications or abnormalities.
d. Neonate/infant outcomes.
e. Infant follow-up for reports of fetal exposure.
3. Failure Mode and Effects Analysis Plan
a. Hoffman La-Roche, or its delegate, will analyze the
incidences of pregnancy in women
exposed to Accutane. Analyses will include patient (monthly)
assessments of the
following:
i Patient interaction with iPLEDGE to determine patient
knowledge, attitudes, and
behavior regarding iPLEDGE requirements.
ii Patient acknowledgement of receipt of educational
materials and contraceptive
counseling.
b. Hoffman La-Roche, or its delegate, will analyze the
root cause for program failure for
patients who become pregnant, including
i Determination of patient knowledge, attitudes, and
behavior regarding iPLEDGE
requirements.
ii Determination of the most likely cause of pregnancy.
B. iPLEDGE Process Compliance Evaluation Plan:
Hoffman La-Roche will submit a Process Compliance Evaluation
Plan by November 12, 2005
designed to monitor, detect, and correct distribution
outside the iPLEDGE program. FDA and
Hoffman La-Roche have agreed that the Process Compliance
Evaluation Plan will include the
following elements as described in the submission dated
August 11, 2005, entitled
“Agreements Needed for Compliance Evaluation Plan.”
The agreed upon plan will be
implemented by January 1, 2006.
1. Wholesaler Compliance: Hoffman La-Roche will:
a. Implement an evaluation plan, as agreed upon with
FDA, to assess wholesaler
compliance with the requirements of the iPLEDGE program
and report on the data
collected in a manner and at the frequency agreed upon
with FDA.
b. Implement a corrective action plan, as agreed upon
with FDA, to address wholesaler
noncompliance with the iPLEDGE program.
2. Pharmacy Compliance: Hoffman La-Roche will:
a. Implement an evaluation plan, as agreed upon with
FDA, to assess pharmacy
compliance with the requirements of the iPLEDGE program
and report on the data
collected in a manner and at the frequency agreed upon
with FDA.
b. Implement a corrective action plan, as agreed upon
with FDA, to address
noncompliance with the iPLEDGE program.
3. Prescriber Compliance: Hoffman La-Roche will:
a. Implement an evaluation plan, as agreed upon with
FDA, to assess prescriber
compliance with the requirements of the iPLEDGE program
and report on the data
collected at the frequency agreed upon with FDA.
b. Implement a corrective action plan to address prescriber
noncompliance with iPLEDGE
requirements.
4. Patient compliance: Hoffman La-Roche will:
a. Implement an evaluation plan to assess patient compliance
with iPLEDGE program
requirements.
i Independent Validation of iPLEDGE Patient Compliance:
Hoffman La-Roche, or its
delegate, will develop an independent means to audit
patient compliance with the
requirements of the iPLEDGE program and to report on
the data collected at the
frequency agreed upon with FDA.
ii Evaluation of patients lost to follow-up or who discontinued
Accutane: Hoffman
La-Roche, or its delegate, will develop a method to
allow evaluation of patients lost
to follow-up or who discontinued Accutane to assess
the reason(s) for no longer
being in iPLEDGE.
b. Implement a corrective action plan to address patient
noncompliance with iPLEDGE.
Back
to the FDA Accutane page
Back
to the Accutane main page
|
|
|
954.777.1111
