Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability, 22157-22159 [E8-9007]
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• Other issues and questions raised
by the workshop attendees or others.
C. Is There a Fee and How Do I Register
for the Workshop?
There is a modest fee to attend the
workshop to defray the costs of meals
provided and other expenses. The fee
for the meeting for registrants from
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D. Where Can I Find Out More About
This Public Workshop?
II. Electronic Access
Persons with access to the Internet
may obtain both the draft guidance
document entitled ‘‘Coronary DrugEluting Stents: Nonclinical and Clinical
Studies’’and the Companion Document
at: https://www.fda.gov/cdrh/ode/
guidance/6255.pdf.
Dated: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8853 Filed 4–23–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Postponement of
Meeting
sroberts on PROD1PC70 with NOTICES
Food and Drug Administration,
HHS.
Notice.
The Food and Drug Administration
(FDA) is postponing the meeting of the
Obstetrics and Gynecology Devices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Commitment Studies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA) is required, under
the Food and Drug Administration
Modernization Act of 1997
(Modernization Act), to report annually
in the Federal Register on the status of
postmarketing study commitments
made by applicants of approved drug
and biological products. This is the
agency’s report on the status of the
studies applicants have agreed to or are
required to conduct.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
Dated: April 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–8845 Filed 4–23–08; 8:45 am]
BILLING CODE 4160–01–S
Background information on the
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at: www.AdvaMed.org and
https://www.fda.gov/cdrh/dsma/
workshop.html.
AGENCY:
Panel of the Medical Devices Advisory
Committee scheduled for May 16, 2008.
The meeting was announced in the
Federal Register of March 27, 2008 (73
FR 16315). FDA’s Center for Devices
and Radiological Health will further
evaluate data relevant to the topic. A
future meeting date will be announced
in the Federal Register.
Contact Person: Michael Bailey,
Center for Devices and Radiological
Health (HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4100, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512524. Please call the Information
Line for up-to-date information on this
meeting.
Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6464,
Silver Spring, MD 20993–0002, 301–
796–0700; or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1400
Rockville Pike, Rockville, MD 20852,
301–827–0373.
SUPPLEMENTARY INFORMATION:
PO 00000
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I. Background
Section 130(a) of the Modernization
Act (Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
requiring reports of certain
postmarketing studies (section 506B of
the act (21 U.S.C. 356b)) for human drug
and biological products. Section 506B of
the act provides FDA with additional
authority to monitor the progress of a
postmarketing study commitment that
an applicant has been required or has
agreed to conduct by requiring the
applicant to submit a report annually
providing information on the status of
the postmarketing study commitment.
This report must also include reasons, if
any, for failure to complete the
commitment. On December 1, 1999 (64
FR 67207), FDA published a proposed
rule providing a framework for the
content and format of the annual
progress report. The proposed rule also
clarified the scope of the reporting
requirement and the timing for
submission of the annual progress
reports. The final rule, published on
October 30, 2000 (65 FR 64607),
modified annual report requirements for
new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) by revising § 314.81(b)(2)(vii)
(21 CFR 314.81(b)(2)(vii)). The rule also
created a new annual reporting
requirement for biologics license
applications (BLAs) by establishing
§ 601.70 (21 CFR 601.70). These
regulations became effective on April
30, 2001. The regulations apply only to
human drug and biological products.
They do not apply to animal drug or to
biological products that also meet the
definition of a medical device.
On September 27, 2007, the President
signed Public Law 110–85, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA). Section 901, in Title
IX of FDAAA, creates a new section
505(o) of the act authorizing FDA to
require certain studies and clinical trials
for prescription drugs and biological
products approved under section 505 of
the act or section 351 of the Public
Health Service Act. This new authority
became effective on March 25, 2008.
FDA is considering how this new
authority will be integrated with
postmarketing commitments. FDA
expects that next year’s report will
reflect this integration.
Sections 314.81(b)(2)(vii) and 601.70
apply to postmarketing commitments
made on or before enactment of the
Modernization Act (November 21, 1997)
as well as those made after that date.
Sections 314.81(b)(2)(vii) and 601.70
require applicants of approved drug and
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
biological products to submit annually a
report on the status of each clinical
safety, clinical efficacy, clinical
pharmacology, and nonclinical
toxicology study that is required by FDA
(e.g., accelerated approval clinical
benefit studies) or that they have
committed to conduct either at the time
of approval or after approval of their
NDA, ANDA, or BLA. The status of
other types of postmarketing
commitments (e.g., those concerning
chemistry, manufacturing, production
controls, and studies conducted on an
applicant’s own initiative) are not
required to be reported under
§§ 314.81(b)(2)(vii) and 601.70 and are
not addressed in this report. It should be
noted, however, that applicants are
required to report to FDA on these
commitments made for NDAs and
ANDAs under § 314.81(b)(2)(viii).
According to the regulations, once a
postmarketing study commitment has
been made, an applicant must report on
the progress of the commitment on the
anniversary of the product’s approval
until the postmarketing study
commitment is completed or terminated
and FDA determines that the
postmarketing study commitment has
been fulfilled or that the postmarketing
study commitment is either no longer
feasible or would no longer provide
useful information. The annual progress
report must include a description of the
postmarketing study commitment, a
schedule for completing the study
commitment, and a characterization of
the current status of the study
commitment. The report must also
provide an explanation of the
postmarketing study commitment’s
status by describing briefly the
postmarketing study commitment’s
progress. A postmarketing study
commitment schedule is expected to
include the actual or projected dates for
the following: (1) Submission of the
study protocol to FDA, (2) completion of
subject accrual or initiation of an animal
study, (3) completion of the study, and
(4) submission of the final study report
to FDA. The postmarketing study
commitment status must be described in
the annual report according to the
following definitions:
• Pending: The study has not been
initiated (i.e., no subjects have been
enrolled or animals dosed), but does not
meet the criterion for delayed (i.e., the
original projected date for initiation of
subject accrual or initiation of animal
dosing has not passed);
• Ongoing: The study is proceeding
according to or ahead of the original
schedule;
• Delayed: The study is behind the
original schedule;
• Terminated: The study was ended
before completion, but a final study
report has not been submitted to FDA;
or
• Submitted: The study has been
completed or terminated, and a final
study report has been submitted to FDA.
Databases containing information on
postmarketing study commitments are
maintained at the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER). Information in this
report covers any postmarketing study
commitment that was made, in writing,
at the time of approval or after approval
of an application or a supplement to an
application, including those required
(e.g., to demonstrate clinical benefit of
a product following accelerated
approval) and those agreed to with the
applicant. Information summarized in
this report includes: (1) The number of
applicants with open (uncompleted)
postmarketing commitments, (2) the
number of open postmarketing
commitments, (3) the status of open
postmarketing commitments as reported
in § 314.81(b)(2)(vii) or § 601.70 annual
reports, (4) the status of concluded
postmarketing studies as determined by
FDA, and (5) the number of applications
with open postmarketing commitments
for which applicants did not submit an
annual report within 60 days of the
anniversary date of U.S. approval.
Additional information about
postmarketing study commitments
made by applicants to CDER and CBER
is provided on FDA’s Web site at https://
www.fda.gov/cder/pmc. Like this notice,
the site does not list postmarketing
study commitments containing
proprietary information. It is FDA
policy not to post information on the
Web site until it has been reviewed for
accuracy. The numbers published in
this notice cannot be compared with the
numbers resulting from searches of the
Web site. This notice incorporates totals
for all postmarketing study
commitments in FDA databases,
including those undergoing review for
accuracy. The report in this notice will
be updated annually while the Web site
is updated quarterly (in January, April,
July, and October).
II. Summary of Information From
Postmarketing Study Progress Reports
This report summarizes the status of
postmarketing commitments as of
September 30, 2007. If a commitment
did not have a schedule or a
postmarketing progress report was not
received, the commitment is categorized
according to the most recent
information available to the agency.
Data in table 1 are numerical
summaries generated from FDA
databases. The data are broken out
according to application type (NDAs/
ANDAs or BLAs).
TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2007)
NDAs/ANDAs
(% of Total)
Applicants with open postmarketing commitments
BLAs1
(% of Total)
136
54
1,281
401
911 (71%)
133 (33%)
Postmarketing commitment created within the last year (FY07)
165 (18%)
41 (31%)
Postmarketing commitment created within the past 2 years (FY06 and FY07)
361 (40%)
99 (74%)
Postmarketing commitment created within the past 3 years (FY05, FY06, and FY07)
489 (54%)
111 (83%)
• Ongoing
173 (14%)
98 (24%)
• Delayed
39 (3%)
86 (22%)
Number of open postmarketing commitments
Status of open postmarketing commitments
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• Pending
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2007)—Continued
NDAs/ANDAs
(% of Total)
• Terminated
BLAs1
(% of Total)
1 (0.1%)
157 (12%)
81 (20%)
133
26
101 (76%)
21 (81%)
1 (<1%)
0
31 (23%)
5 (19%)
115 (37%)2
• Submitted
3 (1%)
41 (51%)
Concluded studies
(October 1, 2006—September 30, 2007)
• Commitment met
• Commitment not met
• Study no longer needed or feasible
Applications with open postmarketing commitments with annual reports due, but not submitted within
60 days of the anniversary date of U.S. approval
1 On
October 1, 2003, FDA completed a consolidation of certain products formerly regulated by CBER into CDER. The previous association of
BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year statistics for CDER BLA postmarketing study commitments will continue to be counted under BLA totals in this table.
2 Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in FY06 for 115/115 (100 percent)
of NDAs/ANDAs and 20/41 (49 percent) of BLAs.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9007 Filed 4–23–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[CFDA Number 93.224; HRSA–09–095,
HRSA–09–096, HRSA–09–097, and HRSA–
09–098]
Amendment to the Fiscal Year 2009
Service Area Competition—New and
Competing Continuation Funding
Health Resources and Services
Administration, HHS.
ACTION: Change in application deadline
and amendment of the available service
areas.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: HRSA is announcing the
reissuance of Fiscal Year 2009 Service
Area Competition—New and Competing
Continuation Funding (HRSA
Announcement Numbers HRSA–09–
095, HRSA–09–096, HRSA–09–097, and
HRSA–09–098). The HRSA Electronic
Handbook (EHB) application deadline
for project periods beginning in
November and December 2008 has been
changed and the list of available service
areas has been updated.
The new EHB application deadline for
HRSA–09–095 is May 9, 2008. (The
grants.gov application deadline of April
7, 2008 remains the same.) All other
VerDate Aug<31>2005
16:15 Apr 23, 2008
Jkt 214001
requirements of HRSA–09–095 remain
the same. Please see the chart on pages
6 and 7 of the guidance for a complete
listing of all application deadlines.
In addition, corrections to two service
areas listed in the Service Area
Competition guidance have been made.
In Appendix F of the guidance,
Bismarck, ND, is incorrectly listed as an
available service area in fiscal year (FY)
2009. The correct service area that is
currently available in FY 2009 is
Beulah, ND. Also, Clay, WV, is
incorrectly listed as an available service
area in FY 2009. The correct service area
that is currently available in FY 2009 is
Blacksville, WV. Bismarck, ND and
Clay, WV, are not available service areas
for the FY 2009 Service Area
Competition. For a complete listing of
all available service areas for the FY
2009 Service Area Competition funding
opportunity, please see Appendix F of
the guidance.
The effective date of this
amended Agency guidance is April 24,
2008.
Background: HRSA administers the
Health Center Program, which supports
more than 4,000 health care delivery
sites, including community health
centers, migrant health centers, health
care for the homeless centers, and
public housing primary care centers.
Health centers serve clients that are
primarily low-income and minorities,
and deliver comprehensive, culturally
competent, quality primary health care
services to patients regardless of their
ability to pay. Charges for health care
services are set according to income.
DATES:
PO 00000
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For
questions regarding this notice, please
contact Nicole Amado in the Office of
Policy and Program Development,
Bureau of Primary Health Care, HRSA,
at 301–594–4300 or
Nicole.Amado@hrsa.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dated: April 17, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–9009 Filed 4–23–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its fifty-ninth meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 2, 2008, 9 a.m.–4:30
p.m. June 3, 2008, 8:45 a.m.–5:15 p.m. June
4, 2008, 8:15 a.m.–10:30 a.m.
Place: Siena Hotel, 1505 East Franklin
Street, Chapel Hill, NC 27514. Phone: 919–
929–4000.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
E:\FR\FM\24APN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 80 (Thursday, April 24, 2008)]
[Notices]
[Pages 22157-22159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Commitment Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is required, under the
Food and Drug Administration Modernization Act of 1997 (Modernization
Act), to report annually in the Federal Register on the status of
postmarketing study commitments made by applicants of approved drug and
biological products. This is the agency's report on the status of the
studies applicants have agreed to or are required to conduct.
FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6464, Silver Spring, MD 20993-0002, 301-
796-0700; or
Robert Yetter, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD
20852, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
Section 130(a) of the Modernization Act (Public Law 105-115)
amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a
new provision requiring reports of certain postmarketing studies
(section 506B of the act (21 U.S.C. 356b)) for human drug and
biological products. Section 506B of the act provides FDA with
additional authority to monitor the progress of a postmarketing study
commitment that an applicant has been required or has agreed to conduct
by requiring the applicant to submit a report annually providing
information on the status of the postmarketing study commitment. This
report must also include reasons, if any, for failure to complete the
commitment. On December 1, 1999 (64 FR 67207), FDA published a proposed
rule providing a framework for the content and format of the annual
progress report. The proposed rule also clarified the scope of the
reporting requirement and the timing for submission of the annual
progress reports. The final rule, published on October 30, 2000 (65 FR
64607), modified annual report requirements for new drug applications
(NDAs) and abbreviated new drug applications (ANDAs) by revising Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec. 601.70 (21 CFR 601.70). These regulations
became effective on April 30, 2001. The regulations apply only to human
drug and biological products. They do not apply to animal drug or to
biological products that also meet the definition of a medical device.
On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, creates a new section 505(o) of the act
authorizing FDA to require certain studies and clinical trials for
prescription drugs and biological products approved under section 505
of the act or section 351 of the Public Health Service Act. This new
authority became effective on March 25, 2008. FDA is considering how
this new authority will be integrated with postmarketing commitments.
FDA expects that next year's report will reflect this integration.
Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing
commitments made on or before enactment of the Modernization Act
(November 21, 1997) as well as those made after that date. Sections
314.81(b)(2)(vii) and 601.70 require applicants of approved drug and
[[Page 22158]]
biological products to submit annually a report on the status of each
clinical safety, clinical efficacy, clinical pharmacology, and
nonclinical toxicology study that is required by FDA (e.g., accelerated
approval clinical benefit studies) or that they have committed to
conduct either at the time of approval or after approval of their NDA,
ANDA, or BLA. The status of other types of postmarketing commitments
(e.g., those concerning chemistry, manufacturing, production controls,
and studies conducted on an applicant's own initiative) are not
required to be reported under Sec. Sec. 314.81(b)(2)(vii) and 601.70
and are not addressed in this report. It should be noted, however, that
applicants are required to report to FDA on these commitments made for
NDAs and ANDAs under Sec. 314.81(b)(2)(viii).
According to the regulations, once a postmarketing study commitment
has been made, an applicant must report on the progress of the
commitment on the anniversary of the product's approval until the
postmarketing study commitment is completed or terminated and FDA
determines that the postmarketing study commitment has been fulfilled
or that the postmarketing study commitment is either no longer feasible
or would no longer provide useful information. The annual progress
report must include a description of the postmarketing study
commitment, a schedule for completing the study commitment, and a
characterization of the current status of the study commitment. The
report must also provide an explanation of the postmarketing study
commitment's status by describing briefly the postmarketing study
commitment's progress. A postmarketing study commitment schedule is
expected to include the actual or projected dates for the following:
(1) Submission of the study protocol to FDA, (2) completion of subject
accrual or initiation of an animal study, (3) completion of the study,
and (4) submission of the final study report to FDA. The postmarketing
study commitment status must be described in the annual report
according to the following definitions:
Pending: The study has not been initiated (i.e., no
subjects have been enrolled or animals dosed), but does not meet the
criterion for delayed (i.e., the original projected date for initiation
of subject accrual or initiation of animal dosing has not passed);
Ongoing: The study is proceeding according to or ahead of
the original schedule;
Delayed: The study is behind the original schedule;
Terminated: The study was ended before completion, but a
final study report has not been submitted to FDA;
or
Submitted: The study has been completed or terminated, and
a final study report has been submitted to FDA.
Databases containing information on postmarketing study commitments
are maintained at the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER).
Information in this report covers any postmarketing study commitment
that was made, in writing, at the time of approval or after approval of
an application or a supplement to an application, including those
required (e.g., to demonstrate clinical benefit of a product following
accelerated approval) and those agreed to with the applicant.
Information summarized in this report includes: (1) The number of
applicants with open (uncompleted) postmarketing commitments, (2) the
number of open postmarketing commitments, (3) the status of open
postmarketing commitments as reported in Sec. 314.81(b)(2)(vii) or
Sec. 601.70 annual reports, (4) the status of concluded postmarketing
studies as determined by FDA, and (5) the number of applications with
open postmarketing commitments for which applicants did not submit an
annual report within 60 days of the anniversary date of U.S. approval.
Additional information about postmarketing study commitments made
by applicants to CDER and CBER is provided on FDA's Web site at https://
www.fda.gov/cder/pmc. Like this notice, the site does not list
postmarketing study commitments containing proprietary information. It
is FDA policy not to post information on the Web site until it has been
reviewed for accuracy. The numbers published in this notice cannot be
compared with the numbers resulting from searches of the Web site. This
notice incorporates totals for all postmarketing study commitments in
FDA databases, including those undergoing review for accuracy. The
report in this notice will be updated annually while the Web site is
updated quarterly (in January, April, July, and October).
II. Summary of Information From Postmarketing Study Progress Reports
This report summarizes the status of postmarketing commitments as
of September 30, 2007. If a commitment did not have a schedule or a
postmarketing progress report was not received, the commitment is
categorized according to the most recent information available to the
agency.
Data in table 1 are numerical summaries generated from FDA
databases. The data are broken out according to application type (NDAs/
ANDAs or BLAs).
Table 1.--Summary of Postmarketing Study Commitments (numbers as of September 30, 2007)
----------------------------------------------------------------------------------------------------------------
NDAs/ANDAs (% of BLAs\1\ (% of
Total) Total)
----------------------------------------------------------------------------------------------------------------
Applicants with open postmarketing commitments 136 54
����������������������������������������������������������������������������������������������������������������
Number of open postmarketing commitments 1,281 401
����������������������������������������������������������������������������������������������������������������
Status of open postmarketing commitments
----------------------------------------------------------------------------------------------------------------
Pending 911 (71%) 133 (33%)
----------------------------------------------------------------------------------------------------------------
Postmarketing commitment created within the last year (FY07) 165 (18%) 41 (31%)
----------------------------------------------------------------------------------------------------------------
Postmarketing commitment created within the past 2 years (FY06 361 (40%) 99 (74%)
and FY07)
----------------------------------------------------------------------------------------------------------------
Postmarketing commitment created within the past 3 years (FY05, 489 (54%) 111 (83%)
FY06, and FY07)
----------------------------------------------------------------------------------------------------------------
Ongoing 173 (14%) 98 (24%)
----------------------------------------------------------------------------------------------------------------
Delayed 39 (3%) 86 (22%)
----------------------------------------------------------------------------------------------------------------
[[Page 22159]]
Terminated 1 (0.1%) 3 (1%)
----------------------------------------------------------------------------------------------------------------
Submitted 157 (12%) 81 (20%)
����������������������������������������������������������������������������������������������������������������
Concluded studies 133 26
(October 1, 2006--September 30, 2007)
----------------------------------------------------------------------------------------------------------------
Commitment met 101 (76%) 21 (81%)
----------------------------------------------------------------------------------------------------------------
Commitment not met 1 (<1%) 0
----------------------------------------------------------------------------------------------------------------
Study no longer needed or feasible 31 (23%) 5 (19%)
����������������������������������������������������������������������������������������������������������������
Applications with open postmarketing commitments with annual reports due, 115 (37%)\2\ 41 (51%)
but not submitted within 60 days of the anniversary date of U.S. approval
----------------------------------------------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain products formerly regulated by CBER into CDER.
The previous association of BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER
and CDER. Fiscal year statistics for CDER BLA postmarketing study commitments will continue to be counted
under BLA totals in this table.
\2\ Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of
U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in
accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using
this definition, annual reports were subsequently submitted in FY06 for 115/115 (100 percent) of NDAs/ANDAs
and 20/41 (49 percent) of BLAs.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9007 Filed 4-23-08; 8:45 am]
BILLING CODE 4160-01-S
