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					    FDA Update
Melissa Greenwald, M.D.
Division of Human Tissues


  AATB Spring Meeting
    Plenary Session
    March 30, 2009
      Orlando, FL
             Today’s Talk
•   OCTGT Office Update
•   Donor Testing
•   Inspections
•   Regulatory Actions
•   Deviation Reports
•   Adverse Reaction Data
•   Follow-Up on Legal Issues
         OCTGT Update
• Three new research programs
  • Retroviral vectors
  • Tissue safety
     • Shyh-Ching Lo
     • Joydeep Ghosh
  • Tolerance and immune regulation
    A new Tissue Laboratory developed under the
   Division of Cellular & Gene Therapies (DCGT) in
  collaboration with the Division of Human Tissues
             (DHT) of OCTGT/CBER/FDA:

• Promote safety of tissue grafts for transplantation
   • Understand and help validation of various procedures for
      human tissue processing
   • Support evaluation of licensed donor screening tests
   • Develop and apply new methodologies for detection of
      microbes in tissues to be used as grafts
   • Develop capability of identification and characterization of
      microbes associated with unusual infections or emerging
      infectious diseases
• Collaborate with OBE and support biovigilance study
  relevant to communicable diseases and disease agents in
  human tissues
Tissue lab capabilities to be developed:

•   Clinical microbiology methodology for detection
    and characterization of various microbes with
    tissue safety concerns
•   Molecular technologies of rapid detection of
    specifically targeted microbes with high
    sensitivity using real-time quantitative PCR
    arrays and viral/pathogen chips
•   Evaluation and application of high-throughput
    sequencing technology for identification of
    unusual microbes or emerging infectious
    disease agents

Many of the capabilities of Tissue lab will be supported
    through outreach and collaborations with various
           laboratories at FDA and at the NIH.
    Guidances in Development
•    Characterization and Qualification of Cell Banks
     Used in the Production of Cellular and Gene
     Therapy Products
•    Use of Serological Tests on Samples from Donors
     of Whole Blood and Blood Components for
     Transfusion and Donors of Human Cells, Tissues,
     and Cellular and Tissue-Based Products (HCT/Ps)
     to Reduce the Risk of Transmission of
     Trypanosoma cruzi infection (OBRR lead)


        Adapted from FDA Annual Guidance Agenda
           (http://first.fda.gov/fedreg/08/oc0860.pdf)
 Guidances in Development
• Preparation of INDs for Certain Unlicensed
  Minimally Manipulated, Unrelated Allogeneic
  Placental/Umbilical Cord Blood Products
  (HPC-C)
• Clinical Study Design for Early Phase Studies
  of Cellular and Gene Therapies
• Clinical Study Design Considerations for
  Cancer Vaccine Development
• Initiation and Conduct of Clinical Trials Using
  Cellular Therapies for Cardiac Disease
 Guidances in Development
• Devices Involved in Manufacture,
  Storage and Administration of Cellular
  Products and Tissues
• Preparation of Investigational Device
  Exemptions and Investigational New
  Drugs for Tissue Engineered and
  Regenerative Medicine Products
• Submission of Information for the
  National Xenotransplantation Database
            Regulation
• Current Good Manufacturing Practice
  and Investigational New Drugs Intended
  for Use in Clinical Trials; Final Rule
  7/15/2008 – effective date 9/15/08
              Guidance
• Draft Guidance for Industry: Validation
  of Growth-Based Rapid Microbiological
  Methods for Sterility Testing of Cellular
  and Gene Therapy Products 2/11/2008
• Guidance for Industry: Content and
  Review of Chemistry, Manufacturing,
  and Control (CMC) Information for
  Human Somatic Cell Therapy
  Investigational New Drug Applications
  (INDs) 4/9/2008
               Guidance
• Draft Guidance for Industry: Use of Nucleic
  Acid Tests to Reduce the Risk of
  Transmission of West Nile Virus from Donors
  of Whole Blood and Blood Components
  Intended for Transfusion and Donors of
  Human Cells, Tissues, and Cellular and
  Tissue-Based Products (HCT/Ps) 4/25/08
   • Two FDA-licensed tests for living and
     cadaveric donors
   • All HCT/P donors tested by Individual
     Donor NAT
   • Comments under review
• Request for Data 7/7/2008
   • Request for complete data for 2008 WNV
     season by 1/31/09
               Guidance
• Guidance for Industry: CGMP for Phase 1
  Investigational Drugs 7/15/2008
   • Well-defined written procedures
   • Adequately controlled equipment and
     manufacturing environment
   • Accurately and consistently recorded data
     from manufacturing (including testing)
• Draft Guidance for Industry: Considerations
  for Allogeneic Pancreatic Islet Cell Products
  5/21/2008
               Guidance

• Guidance for FDA Reviewers and Sponsors:
  Content and Review of Chemistry,
  Manufacturing, and Control (CMC)
  Information for Human Gene Therapy
  Investigational New Drug Applications (INDs)
  - 4/9/2008
• Draft Guidance for Industry: Potency Tests for
  Cellular and Gene Therapy Products -
  10/9/2008
            Guidance

• Draft Guidance for Industry: Current
  Good Tissue Practice (CGTP) and
  Additional Requirements for
  Manufacturers of Human Cells, Tissues,
  and Cellular and Tissue-Based
  Products (HCT/Ps) - 1/16/2009
             Guidance
• Draft Guidance for Industry: Use of
  Serological Tests to Reduce the Risk of
  Transmission of Trypanosoma cruzi
  Infection in Whole Blood and Blood
  Components for Transfusion and
  Human Cells, Tissues, and Cellular and
  Tissue-Based Products (HCT/Ps) -
  3/26/2009
             Guidance
• Draft Chagas guidance, cont.
  • Not for implementation
  • Notification of intent to make Chagas
    Disease (T. cruzi infection) a RCDAD
  • Makes recommendations for donor
    screening and testing
  • Docket open for comments
    Regulations/Guidance
• http://www.fda.gov/cber/guidelines.htm
• http://www.fda.gov/cber/rules.htm
     Meetings/Workshops
• Animal Models for the Treatment of Acute
  Radiation Syndrome September 17-18, 2008
• Public Workshop: America’s Blood Centers:
  Blood Establishment Computer Software
  (BECS) Conference July 10-11, 2008
• FDA Workshop to Consider Approaches to
  Reduce the Risk of Transfusion-Transmitted
  Babesiosis in the United States September
  12, 2008
      Meetings/Workshops
• Blood Products Advisory Committee (1 April
  2009); one topic will discuss blood donor
  screening, and testing donors of human cells,
  tissues, and cellular and tissue-based
  products (HCT/Ps) for hepatitis B virus
  infection by nucleic acid testing
• http://www.fda.gov/cber/advisory/bp/bp0409.h
  tm
     Meetings/Workshops
• http://www.fda.gov/cber/minutes/worksh
  op-min.htm
• http://www.fda.gov/cber/scireg.htm
HCT/P Donor Tests for RCDADs
   • Updated listing of all
     available donor screening
     tests and appropriate
     specimens (originally
     posted Feb 2007) at:
     http://www.fda.gov/cber/ti
     ssue/prod.
     htm#approved
   • Specific testing
     requirements listed at:
     http://www.fda.gov/cber/ti
     ssue/hctptestreq.htm
  HRSA RFI on Vascularized
    Composite Allografts
• HRSA seeking comment on whether
  vascularized composite allografts should be
  included in definition of organ
• See Request for Information (RFI) at:
  http://www.gpoaccess.gov/fr/index.html
• Public meeting April 4, 2008 at Parklawn
  Bldg, Rockville MD
• Comment period closed May 2, 2008
• Contact HRSA for more info:
  301-443-7577
General Testing Requirements
• 1271.80(c) Tests. You must test using
  appropriate FDA-licensed, approved, or
  cleared donor screening tests, in
  accordance with the manufacturer’s
  instructions, to adequately and
  appropriately reduce the risk of
  transmission of relevant communicable
  diseases.
 Maximum specimen storage claims in
 selected HCT/P donor screening tests
• HCV NAT:
   • COBAS Ampliscreen HCV Test, version 2.0:
     Living donor (LD) specimens, maximum time
     frozen is one month; cadaveric specimens (CAD)
     up to 72 hours.
   • COBAS Taqscreen MPX: LD maximum time
     frozen 30 days, No current CAD claim
   • Procleix HIV-1/HCV Assay: LD 5 days at 2-8;
     “longer periods of time at </= -20 degrees C” [a
     specific time-frame has not been validated]; CAD
     “long term storage of plasma at </= -20 has not
     been established”
   • Procleix Ultrio Assay: LD up to 6 months frozen,
     CAD up to 2 weeks
Maximum specimen storage claims in
selected HCT/P donor screening tests

• HIV NAT: same as for HCV NAT
  • COBAS Ampliscreen HIV-1 Test has
    same storage claim as the
    Ampliscreen HCV test – up to one
    month
  • all other tests are the same
 Antibody Test Storage Claims
• Many have language similar to below*:

  For cadaveric specimens, follow general standards
  and/or regulations for collection, storage and
  handling. Cadaveric specimens may be stored frozen
  (-20°C or colder) or stored for up to 2 days at 2 - 8°C.
  If storage periods greater than 2 days at 2 - 8°C are
  anticipated, the serum should be removed from the
  clot to avoid hemolysis and stored frozen.
* Abbott PRISM HBsAg Assay
 Antibody Test Storage Claims
Ortho HCV and Chagas ELISA tests (Ab)
• Cadaveric specimens may be stored for up to 10
  days at 2-8°C and up to 4 weeks at –20°C
  undergoing 5 freeze/thaw cycles. Store specimens in
  appropriately qualified freezers. Specimens may be
  frozen and thawed up to 5 times. Mix specimen
  thoroughly after thawing and before testing.
• Studies have demonstrated that specimens may be
  shipped at ambient temperature (up to 37°C) for up to
  seven days or refrigerated (2 to 8°C) for up to seven
  days. Upon arrival, specimens should be stored at 2
  to 8°C. For shipments requiring extensive transit
  times (greater than seven days), specimens should
  be kept frozen (-20°C or below).
                    FY08 HCT/P
             Inspections Accomplished
   Type of HCT/P                     # Inspections           Hours/
   establishment                     Accomplished            Inspection

   Reproductive tissues              158                     42.4
   Cord blood stem cells             19                      31.7
   Peripheral blood stem cells

   All other HCT/Ps                  213                     34.4
   (e.g. musculoskeletal, ocular,
   recovery, distributors)

   Total                             383*                    37.5
*Sum of individual inspections do not equal total due to some inspections that
were conducted for products in multiple categories
          FY08 HCT/P
    Inspection Classifications
Type of HCT/P            NAI   VAI   OAI
establishment
Reproductive tissues     106   40    10

Cord blood stem cells    15     4     0
Peripheral blood stem
cells
All other HCT/Ps         164   46     1
(e.g. musculoskeletal,
ocular, recovery,
distributors)
Total                    285   90    11
              FDA Form 483

• “This document lists observations made by the FDA
  representative(s) during the inspection of your facility.
  They are inspectional observations, and do not
  represent a final agency determination regarding your
  compliance. If you have an objection regarding an
  observation, or have implemented, or plan to
  implement, corrective action in response to an
  observation, you may discuss the objection or action
  with the FDA representative(s) during the inspection
  or submit this information to FDA at the address
  above….”
OAI/VAI/NAI?

• OAI – Official Action Indicated – objectionable
  conditions found that warrant action
• VAI – Voluntary Action Indicated –
  objectionable conditions found but do not
  meet the threshold for regulatory action
• NAI – No Action Indicated – no objectionable
  conditions found (generally no FDA-483)
• http://www.fda.gov/ora/inspect_ref/fmd/fmd86
  .htm
         FY08 HCT/P
      Inspection Results

• Approx. 30% of HCT/P inspections
  resulted in issuance of Form FDA-483s;
• Consistent with FY07 and FY06.
   Inspectional Observations:
    Storage and Distribution
• Failure to store HCT/Ps at appropriate temperatures;
  establish acceptable temperature limits; and/or
  maintain and record storage temperatures 21 CFR
  1271.260 (b) and (e)
   • Storage room temperatures are not
     recorded
   • Freezer did not have a functioning
     recording device and was not equipped
     with an alarm. The freezer temperature is
     not recorded or monitored after normal
     operating hours
   • Temperature monitoring logs not reviewed
     prior to removal/transfer of grafts as
     required in the SOP
    Inspectional Observations:
            Processors
• Failure to maintain facility in good state of repair 21
  CFR 1271.190(a)
   • Several processing rooms have damage to the
     walls – areas of damage show exposed dry wall
     below the level of the paper layer
• Failure to maintain documentation of equipment
  maintenance, cleaning, sanitization and calibration 21
  CFR 1271. 200(e)
   • Cleaning of equipment was not documented.
     There were no records of cleaning from 1/2006 –
     3/2008
   Inspectional Observations:
         Processors - 2
• Failure to process HCT/Ps in a way that does
  not increase the risk of introduction,
  transmission or spread of communicable
  disease 21 CFR 1271.220(a)
   • There were five occurrences where
     containers holding tissue from two different
     donors were opened at the same time in
     the processing hood. (Note – a cross
     contamination event had been
     documented)
   Inspectional Observations:
         Donor Testing
• Failure to perform testing for
  communicable disease agents
  according to the manufacturer’s
  instructions 21 CFR 1271.80(c)
   • Cadaveric samples tested by NAT
     assay were routinely tested using a
     1:5 dilution. The package insert
     instructs that cadaveric donors be
     tested “neat.”
       Regulatory Actions
• Regulatory Actions Issued
  • 1 Warning Letter (repro)
  • 1 Untitled Letter (repro)
  • 1 Untitled Letter –website/stem cell
    treatment – part of our internet
    surveillance
    FY08 HCT/P Regulatory
   Actions: Deviations Cited
• Failure to test specimens from anonymous or
  directed reproductive donors using appropriate FDA-
  licensed, approved, or cleared donor screening
  tests, in accordance with the manufacturer's
  instructions 21 CFR 1271.80(c).
• Failure to screen an anonymous or directed
  reproductive donor of cells or tissue by reviewing the
  donor's relevant medical records for risk factors for,
  and clinical evidence of, relevant communicable
  disease agents and diseases 21 CFR 1271.75(a).
      Regulatory Actions - 2
• Failure to establish and maintain procedures for all
  steps that are performed in testing, screening,
  determining donor eligibility, and complying with all
  other requirements of Subpart C "Donor Eligibility" in
  21 CFR Part 1271. "Establish and maintain" means
  define, document, and implement; then follow,
  review, and as needed, revise on an ongoing basis
  [21 CFR 1271.47(a)].
   • The firm's standard operating procedures did not address all
     steps required for donor screening and determining donor
     eligibility, including, but not limited to: (1) donor screening for
     risk factors for, or clinical evidence of relevant communicable
     disease agents and diseases; and (2) the criteria used to
     determine donor eligibility and ineligibility.
   HCT/P Deviation Reporting

                 FY06    FY07    FY08

Reportable        144     153     223
Electronic        100     118     164
Reports          (69%)   (77%)   (74%)

Non-Reportable    76      48      63

Total Reports    220     201     286
      HCT/P Deviation Reports
           Products Involved
Product                 FY06 FY07 FY08
Peripheral Blood Stem
Cells                     71   98   109
Cornea/Sclera             51   35    44
Skin                       6    6    27
Musculoskeletal           21   14    26
Somatic Cells              0    1    19
Donor Leukocytes           6   10    12
Cord Blood Stem Cells      2    4     4
        HCT/P Deviations Reported
Reportable HCT/P            FY 05   FY 06   FY 07   FY 08
Deviations
Donor Eligibility               8      32      24      37
Donor Screening                 0      12       8      17
Donor Testing                   0      33      54      54
Environmental Control           0       1       2       0
Supplies and Reagents           0       3       6       1
Recovery                        0       2       8       8
Processing                      0      14      17      68
Labeling Control                1       2       1       2
Storage                         0       1       0       0
Receipt, Pre-Dist., Dist.       4      43      32      36
Total                          13     143     152     223
Non-Reportable                 15      77      48      63
      HCT/P Deviation Reports
       Non-Reportable Events
• No products were distributed
• Not associated with disease transmission or
  contamination
• Not related to core GTP
• Product released under urgent medical need
• Product not subject to HCT/P deviation reporting
   • Reproductive tissue
   • Unrelated Allogeneic Stem Cells
• Reporting establishment is not an HCT/P
  manufacturer
    HCT/P Deviation Reports
     Non-Reportable Events
• Positive pre-implant culture is in
  general not reportable as a deviation
   • Unless a complaint results in an
     investigation that reveals a
     departure from GTPs or
   • If the recipient had an adverse
     reaction then might be reported as
     an adverse reaction not HCT/P
     deviation
HCT/P Deviation Reporting FY08
                             Cellular   Tissue
HCT/P Deviation Code         HCT/P      HCT/P         Total
Donor Eligibility                  4        33   37      16.6%
Donor Screening                    2        15   17       7.6%
Donor Testing                      42       12   54      24.2%
Environmental Control              0         0   0        0.0%
Supplies and Reagents              1         0   1        0.4%
Recovery                           8         0   8        3.6%
Processing and
Processing Controls                50       18   68      30.5%
Labeling Controls                  0         2   2        0.9%
Storage                            0         0   0        0.0%
Receipt, Pre-Distribution,
Shipment & Distribution            33        3   36      16.1%
Total                             140       83   223     100%
     Tissue HCT/P Reports
• Donor Eligibility – 33 reports
  • Donor accepted when risk factors, clinical
    evidence or physical evidence identified –
    18
  • Donor accepted when reactive for relevant
    communicable disease – 4
  • Donor incorrectly evaluated for plasma
    dilution – 10
  • Donor testing not performed or
    documented - 1
  Tissue HCT/P Reports - 2
• Processing and process controls – 18
  • HCT/P contaminated, potentially
    contaminated or cross contaminated – 17
  • In-process controls inadequate – 1

• Microorganisms involved:
  • Bacillus, Candida, Clostridium,
    Enterobacter, Group D Enterococcus,
    Staphylococcus, Proteus
  Tissue HCT/P Reports - 3
• Donor Screening – 15
  • Donor screening not performed or
    documented – 1
  • Donor screening (medical history
    interview) performed incorrectly
    (incomplete or inaccurate) – 13
  • Donor screening (medical record
    review) performed incorrectly
    (incomplete or inaccurate) - 1
         Classified Recalls
             FY 2007
                  HCT/P      CBER Total
                  Recalls       Recalls
                            (all products)
FY 07 Class I       7              7

FY 07 Class II      15          1041

FY 07 Class III     0           381
              Classified Recalls
                  FY 2008*
                                HCT/P                    CBER Total
                                Recalls                     Recalls
                                                        (all products)
FY 08 Class I                        3                         4

FY 08 Class II                      11                      950

FY 08 Class III                      7                      345

* This table does not include 3 “mixed class” recalls
           FY 2008 Class I
           HCT/P Recalls
• Donors met all DE requirements using
  diagnostic HBsAg and HBcAb tests. Re-
  testing of donors using FDA licensed donor
  screening tests revealed three donors
  reactive (confirmed positive) for HBsAg
  • 2 recalls
• Clostridium perfringens infection in recipient.
                  HCT/P Recalls
45
40
35
30
25                                                  Class I
20                                                  Class II
15                                                  Class III

10
5
0
     FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08
Adverse Reaction Data
   Adverse Reactions Reported*
         by Tissue Type
Tissue type                CY 2005        CY 2006        CY 2007        CY 2008**
Total Infections           35             98             91             77
Bone                       9              26             21             9
Musculoskeletal
Tissue                     4              21             38             29
Skin                       12             22             18             18
Eye                        8              27             12             16
Cardiac                    1              1              1              2
Blood Vessel               1              1              0              1
Tissue, NOS                0              0              1              2
 *Numbers   reflect reports, not confirmed cases. Most reports are of routine post-op
 infections and it is difficult to conclusively distinguish if allograft-related.
 ** 2008   includes reports received 1/1 through 12/11/ 2008
             Reported Adverse
           Reactions by Outcome

 Type of event            2005*         2006         2007      2008**   Total


Infectious AE               35           98              91     77      301

Non-Infectious
  AE                        20           32              27     25      104


No AE                       20           17               6     18       61


Total                       75           147             124    120     466
  * Data   for 2005 includes only reports after May 25
  ** Includes   reports received 1/1/08-12/16/2008
   Reported Adverse Reactions
     by Reported Organism
       2006         2007        2008**           Organism
         57           63          45             Bacteria
          6           5           12              Fungi
         23           8            3              Virus



                                   3               CJD
         12           15          14             Unknown
         98           91          77               Total


** Includes reports received 1/1/08-12/16/2008
   Biomedical Tissue Services (BTS)
   Order to Cease and Retain HCT/Ps

• Immediately cease manufacturing operations and
  retain HCT/Ps.
• To BTS and its CEO and Executive Director, Michael
  Mastromarino, D.D.S.
• After initially focusing efforts on assessing the safety
  of distributed tissue and facilitating recalls, FDA
  determined that the violations uncovered at BTS,
  because of their serious nature, constitute a danger
  to health and took this unprecedented action
• Order to Cease Manufacturing and to Retain HCT/Ps
  issued January 31, 2006
• www.fda.gov/cber/compl/bts013106.htm
                BTS Order
• Despite records maintaining otherwise:
   • The firm inadequately screened donors for
     risk factors for, or clinical evidence of,
     relevant communicable disease agents and
     diseases;
   • FDA found numerous instances where death
     certificates maintained in BTS’ files were at
     variance with the death certificates FDA
     obtained from the state where the death
     occurred:
       • Cause, place, and time of death, and the
         identity of next of kin.
• FDA continued to work with other federal, state
  and local authorities
           CDC: MMWR
    Brief Report May 26, 2006
• “Investigation into Recalled Human Tissue for
  Transplantation---United States, 2005--2006.”
• Approximately 25,000 BTS-recovered tissue
  products distributed to all 50 states and
  internationally
• FDA and CDC continue to investigate reports
  of BTS recipients who have undergone
  screening and tested positive for one of the
  four tested diseases
• Some positive results would be expected in
  any U.S. population tested (prevalence data
  provided)
           MMWR cont..
• Relationship between implanted BTS
  tissue and positive test results reported
  to FDA and CDC is difficult to ascertain
  because of inaccurate BTS donor
  records and, in some cases, the
  absence of properly linked donor
  samples.
              BTS Update
• In March 2008, Michael Mastromarino pleaded guilty
  in Brooklyn Supreme Court to body stealing, forgery,
  grand larceny and enterprise corruption and was
  sentenced to 18 to 54 years. He is serving a
  concurrent sentence of 25 to 58 years after pleading
  guilty to similar changes in Philadelphia.
• Co-defendant Lee Cruceta pleaded guilty to
  conspiracy, taking part in a corrupt organization,
  abuse of a corpse and 244 counts each of theft and
  forgery in Philadelphia and also has pleaded guilty
  to related charges in Brooklyn and negotiated pleas
  to serve concurrent sentences of 6½ to 20 years.
• Co-defendant Chris Aldorasi was found guilty of
  enterprise corruption and other criminal counts in
  Brooklyn and sentenced to 9 to 27 years.
            BTS Update - 2
• Co-defendant Joseph Nicelli has yet to stand trial in
  Brooklyn
• On December 12, 2008, Jason Gano, a former
  funeral director in Rochester, NY, was found guilty of
  17 counts each of opening graves, body stealing, and
  unlawful dissection, as well as one count of scheming
  to defraud. He faces up to 20 years in prison when
  he is sentenced.
• Six others are expected to stand trial in Rochester
• FDA will continue to work cooperatively with other
  Federal, State and local authorities
 Donor Referral Services (DRS) Order to
 Cease Manufacturing and Retain HCT/Ps

• Immediately cease manufacturing operations
  and retain HCT/Ps.
• To DRS and its Owner, Philip Guyett
• FDA determined that the violations uncovered
  at DRS, because of their serious nature,
  constitute a danger to health and took action
• Order to Cease Manufacturing and to Retain
  HCT/Ps issued 18 August, 2006
• http://www.fda.gov/cber/compl/drs081806.htm
            DRS Order
• FDA found numerous instances where
  information provided by DRS to a tissue
  processor was at variance with the
  death certificates FDA obtained from
  the state where the death occurred:
     • Cause, place, and time of
       death
DRS Public Health Notification
• August 30, 2006
• FDA and CDC strongly recommended health
  care providers inform all patients that
  received tissue initially recovered by DRS
  and offer access to communicable disease
  testing
• Distributing firms had already voluntarily
  recalled tissue in inventory
• Where FDA had previously identified specific
  cases of concern, the firms cooperated fully in
  efforts to inform patients and offer testing in
  those cases
              DRS Update

• On March 9, 2009, Philip Guyett pleaded
  guilty in U.S District Court in Raleigh, North
  Carolina to three counts of mail fraud
• He is scheduled to be sentenced June 1,
  2009, and faces up to 60 years in prison and
  $750,000 in fines
• FDA continues to investigate DRS working
  with other federal, state and local authorities
       CBER Information
• Web site
  • http://www.fda.gov/cber
  • http://www.fda.gov/cber/tiss.htm
• E-mail
  • Manufacturers: matt@cber.fda.gov
  • Consumers, health care:
    octma@cber.fda.gov
• Phone
  • 301-827-1800

				
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