-
1
-
-
84897005978
-
Multistate Point-Prevalence Survey of Health Care-Associated Infections
-
Shelley S.Magill et al., Multistate Point-Prevalence Survey of Health Care-Associated Infections, 370NEW ENG. J. MED. 1198, 1198 (2014)
-
(2014)
NEW ENG. J. MED
, vol.370
, pp. 1198-1198
-
-
Magill, S.S.1
-
2
-
-
45249099998
-
Increase in Adult Clostridium Difficile-Related Hospitalizations and Case-Fatality Rate, United States, 2000-2005
-
Marya D. Zilberberg, Andrew F. Shorr & Marin H. Kollef, Increase in Adult Clostridium Difficile-Related Hospitalizations and Case-Fatality Rate, United States, 2000-2005, 14 EMERG. INFECT. DIS. 929, 929 (2008)
-
(2008)
EMERG. INFECT. DIS
, vol.14
, pp. 929-929
-
-
Zilberberg, M.D.1
Shorr, A.F.2
Kollef, M.H.3
-
3
-
-
85054958362
-
-
Mar(accessed June 18, 2015)
-
The White House, National Action Plan for Combating Antibiotic-Resistant Bacteria, 60, Mar. 2015, https://www.whitehouse.gov/sites/default/files/docs/national action plan for combating antiboticresistant bacteria.pdf (accessed June 18, 2015)
-
(2015)
National Action Plan for Combating Antibiotic-Resistant Bacteria
, vol.60
-
-
-
4
-
-
84863694101
-
Burden of Clostridium Difficile on the Healthcare System
-
Erik R. Dubberke & Margaret A. Olsen, Burden of Clostridium Difficile on the Healthcare System, 55 CLIN. INFECT. DIS. S88, S88 (2012)
-
(2012)
CLIN. INFECT. DIS
, vol.55
, pp. S88-S88
-
-
Dubberke, E.R.1
Olsen, M.A.2
-
5
-
-
55249105923
-
Clostridium Difficile-More Difficult Than Ever
-
Ciaran P. Kelly & J.Thomas LaMont, Clostridium Difficile-More Difficult Than Ever, 359 NEW ENG. J. MED. 1932, 1936 (2008)
-
(2008)
NEW ENG. J. MED
, vol.359
, pp. 1932-1936
-
-
Kelly, C.P.1
Thomas LaMont, J.2
-
6
-
-
84863923754
-
Decreased Cure and Increased Recurrence Rates forClostridiumDifficile InfectionCaused by the Epidemic C. Difficile BI Strain
-
Laurica A. Petrella et al., Decreased Cure and Increased Recurrence Rates forClostridiumDifficile InfectionCaused by the Epidemic C. Difficile BI Strain, 55CLIN. INFECT. DIS. 351, 352 (2012)
-
(2012)
CLIN. INFECT. DIS
, vol.55
, pp. 351-352
-
-
Petrella, L.A.1
-
7
-
-
84900434000
-
Cost-Effectiveness of Competing Strategies for Management of Recurrent Clostridium Difficile Infection: A Decision Analysis
-
Gauree G. Konijeti et al., Cost-Effectiveness of Competing Strategies for Management of Recurrent Clostridium Difficile Infection: A Decision Analysis, 58CLIN. INFECT. DIS. 1507, 1507 (2014)
-
(2014)
CLIN. INFECT. DIS
, vol.58
, pp. 1507-1507
-
-
Konijeti, G.G.1
-
8
-
-
84898542092
-
Treatment of Recurrent Clostridium Difficile Infection: A Systematic Review
-
J. C. O'Horo et al., Treatment of Recurrent Clostridium Difficile Infection: A Systematic Review, 42 INFECTION 43, 43 (2014)
-
(2014)
INFECTION
, vol.42
, pp. 43-43
-
-
O'Horo, J.C.1
-
9
-
-
84923918647
-
Review of the Emerging Treatment of Clostridium difficile Infection with Fecal Miocrobiota Transplantation and Insights into Future Challenges
-
Zain Kassam, Christine H. Lee & Richard H. Hunt, Review of the Emerging Treatment of Clostridium difficile Infection with Fecal Miocrobiota Transplantation and Insights into Future Challenges, 34 CLIN. LAB. MED. 787 (2014)
-
(2014)
CLIN. LAB. MED
, vol.34
, pp. 787
-
-
Kassam, Z.1
Lee, C.H.2
Hunt, R.H.3
-
10
-
-
85054997884
-
-
May 2(accessed June 18, 2015)
-
Food & Drug Administration, Fecal Microbiota for Transplantation: Scientific and Regulatory Issues 309, May 2, 2013, http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetings Conferences/UCM352903.pdf (accessed June 18, 2015)
-
(2013)
Fecal Microbiota for Transplantation: Scientific and Regulatory
, Issue.309
-
-
-
11
-
-
84862309942
-
Standardized Frozen Preparation for Transplantation of Fecal Microbiota for Recurrent Clostridium difficile Infection
-
supplementary appendix 1
-
Matthew J. Hamilton et al., Standardized Frozen Preparation for Transplantation of Fecal Microbiota for Recurrent Clostridium difficile Infection, 107 AM. J. GASTROENTEROL 761, supplementary appendix 1 (2012)
-
(2012)
AM. J. GASTROENTEROL
, vol.107
, pp. 761
-
-
Hamilton, M.J.1
-
12
-
-
0001412472
-
FecalEnema as an Adjunct in the Treatment of PseudomembranousEnterocolitis
-
BenEiseman et al., FecalEnema as an Adjunct in the Treatment of PseudomembranousEnterocolitis, 44 SURGERY 854 (1958)
-
(1958)
SURGERY
, vol.44
, pp. 854
-
-
Eiseman, B.1
-
13
-
-
84875952542
-
FecalMicrobiota for Clostridium difficile Infection: Systematic Review andMeta-Analysis
-
Zain Kassam et al., FecalMicrobiota for Clostridium difficile Infection: Systematic Review andMeta-Analysis, 108 AM. J. GASTROENTEROL 500, 508 (2013)
-
(2013)
AM. J. GASTROENTEROL
, vol.108
, pp. 500-508
-
-
Kassam, Z.1
-
14
-
-
84898906169
-
Systematic Review: FaecalMicrobiota Transplantation Therapy for Digestive and Nondigestive Disorders in Adults and Children
-
Sumei Sha et al., Systematic Review: FaecalMicrobiota Transplantation Therapy for Digestive and Nondigestive Disorders in Adults and Children, 39 ALIMENT. PHARMACOL. THER. 1003, 1004 (2014)
-
(2014)
ALIMENT. PHARMACOL. THER
, vol.39
, pp. 1003-1004
-
-
Sha, S.1
-
15
-
-
84873019302
-
Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile
-
Els van Nood et al., Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile, 368 NEW ENG. J. MED. 407, 409 (2013)
-
(2013)
NEW ENG. J. MED
, vol.368
, pp. 407-409
-
-
van Nood, E.1
-
16
-
-
84863719891
-
Long-Term Follow-up of Colonoscopic Fecal Microbiota Transplant for Recurrent Clostridium difficile Infection
-
Lawrence J. Brandt, et al., Long-Term Follow-up of Colonoscopic Fecal Microbiota Transplant for Recurrent Clostridium difficile Infection, 107 AM. J.GASTROENTEROL. 1079, 1079 (2012)
-
(2012)
AM. J.GASTROENTEROL
, vol.107
, pp. 1079-1079
-
-
Brandt, L.J.1
-
17
-
-
84874737205
-
High-Throughput DNA Sequence Analysis Reveals Stable Engraftment of Gut Microbiota Following Transplantation of Previously Frozen Fecal Bacteria
-
Matthew J. Hamilton et al., High-Throughput DNA Sequence Analysis Reveals Stable Engraftment of Gut Microbiota Following Transplantation of Previously Frozen Fecal Bacteria, 4 GUTMICROBES 125 (2013)
-
(2013)
GUTMICROBES
, vol.4
, pp. 125
-
-
Hamilton, M.J.1
-
18
-
-
84925500413
-
PrecisionMicrobiome Reconstitution Restores Bile AcidMediated Resistance to Clostridium difficile
-
CharlieG. Buffie et al., PrecisionMicrobiome Reconstitution Restores Bile AcidMediated Resistance to Clostridium difficile, 517 NATURE 205 (2015)
-
(2015)
NATURE
, vol.517
, pp. 205
-
-
Buffie, C.G.1
-
21
-
-
85054977078
-
-
Aug. 7(accessed June 18, 2015)
-
OpenBiome, OpenBiome Receives Grant to Support FMT Patient Safety Study, Aug. 7, 2014, http://www. openbiome.org/press-releases/2014/8/8/openbiome-receives-grant-to-support-fmt-patient-safety-study (accessed June 18, 2015)
-
(2014)
OpenBiome Receives Grant to Support FMT Patient Safety Study
-
-
-
22
-
-
84904264732
-
Canadian Association of Gastroenterology Position Statement: Fecal Microbiota TransplantTherapy
-
Paul Moayyedi et al., Canadian Association of Gastroenterology Position Statement: Fecal Microbiota TransplantTherapy, 28, CAN. J. GASTROENTEROL. HEPATOL. 66, 67 (2014)
-
(2014)
CAN. J. GASTROENTEROL. HEPATOL
, vol.28
, pp. 66-67
-
-
Moayyedi, P.1
-
23
-
-
85054954191
-
With Vedanta Deal
-
XCONOMY, Jan. 13(accessed June 18, 2015)
-
Alex Lash, With Vedanta Deal, J & J Marks Big-Pharma Milestone in the Microbiome, XCONOMY, Jan. 13, 2015, http://www.xconomy.com/boston/2015/01/13/with-vedanta-deal-jj-marks-big-pharma-milestonein-the-microbiome/ (accessed June 18, 2015)
-
(2015)
J & J Marks Big-Pharma Milestone in the Microbiome
-
-
Lash, A.1
-
24
-
-
85054957697
-
-
Announcement of May 2013 Workshop(accessed June 18, 2015)
-
Food & Drug Administration, Public Workshop: Fecal Microbiota for Transplantation, Announcement of May 2013 Workshop, http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetings Conferences/ucm341643.htm (accessed June 18, 2015)
-
Public Workshop: Fecal Microbiota for Transplantation
-
-
-
25
-
-
84894241861
-
How to Regulate Faecal Transplants
-
Mark B. Smith, Colleen Kelly & Eric J.Alm, How to Regulate Faecal Transplants, 506NATURE 290, 290 (2014)
-
(2014)
NATURE
, vol.506
, pp. 290-290
-
-
Smith, M.B.1
Kelly, C.2
Alm, E.J.3
-
26
-
-
79957574938
-
Moving Pictures of the Human Microbiome
-
J. Gregory Caporaso et al., Moving Pictures of the Human Microbiome, 12GENOME BIOL. R50 (2011)
-
(2011)
GENOME BIOL
, vol.12
, pp. R50
-
-
Gregory Caporaso, J.1
-
27
-
-
84910057313
-
Host Lifestyle Affects Human Microbiota on Daily Timescales
-
Lawrence A. David et al., Host Lifestyle Affects Human Microbiota on Daily Timescales, 15 GENOME BIOL. R89 (2014)
-
(2014)
GENOME BIOL
, vol.15
, pp. R89
-
-
David, L.A.1
-
28
-
-
0027848806
-
The Orphan Drug Regulations and Related Issues
-
Joseph A. Levitt&John V. Kelsey, The Orphan Drug Regulations and Related Issues, 48 FOOD & DRUG L.J. 525, 526-28 (1993)
-
(1993)
FOOD & DRUG L.J
, vol.48
-
-
Levitt, J.A.1
Kelsey, J.V.2
-
29
-
-
84892221533
-
Patents vs. Statutory Exclusivities in Biological Pharmaceuticals-Do We Really Need Both?
-
Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals-Do We Really Need Both?, 18MICH. TELECOMM. & TECH. L. REV. 419, 423 n.5 (2012)
-
(2012)
MICH. TELECOMM. & TECH. L. REV
, vol.18
, Issue.5
, pp. 419-423
-
-
Heled, Y.1
-
30
-
-
2442446865
-
The Shifting Functional Balance of Patents and Drug Regulation
-
Rebecca S. Eisenberg, The Shifting Functional Balance of Patents and Drug Regulation, 19 HEALTH AFF. 119, 122 (2001)
-
(2001)
HEALTH AFF
, vol.19
, pp. 119-122
-
-
Eisenberg, R.S.1
-
31
-
-
0347079845
-
The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era
-
Arti K. Rai, The Information Revolution Reaches Pharmaceuticals: Balancing Innovation Incentives, Cost, and Access in the Post-Genomics Era, 2001 U. ILL. L. REV. 173, 183 (2001)
-
(2001)
U. ILL. L. REV
, vol.2001
, pp. 173-183
-
-
Rai, A.K.1
-
32
-
-
0347141505
-
The Architecture of Government Regulation of Medical Products
-
Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1790-91 (1996)
-
(1996)
VA. L. REV
, vol.82
-
-
Merrill, R.A.1
-
33
-
-
77953158446
-
Incentives for Drug Development-The Curious Case of Colchicine
-
Aaron S. Kesselheim & DanielH. Solomon, Incentives for Drug Development-The Curious Case of Colchicine, 362 NEW ENG. J. MED. 2045, 2045 (2010)
-
(2010)
NEW ENG. J. MED
, vol.362
, pp. 2045-2045
-
-
Kesselheim, A.S.1
Solomon, D.H.2
-
34
-
-
84865635252
-
Hydroxyprogesterone Caproate Injection (Makena) One Year Later
-
Yesha Patel & Martha M. Rumore, Hydroxyprogesterone Caproate Injection (Makena) One Year Later, 37 P&T 405, 406 (2012)
-
(2012)
P&T
, vol.37
, pp. 405-406
-
-
Yesha, P.1
Rumore, M.M.2
-
36
-
-
85054971633
-
-
Mar. 10(accessed June 18, 2015)
-
Food & Drug Administration, Orphan Drug Designation for Fecal Microbiota, Mar. 10, 2014, http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD Results 2.cfm?Index Number=421013 (accessed June 18, 2015)
-
(2014)
Orphan Drug Designation for Fecal Microbiota
-
-
-
38
-
-
85054961587
-
Should We Regulate Poop as a Drug?
-
Aug. 18(accessed June 18, 2015)
-
Alex Park, Should We Regulate Poop as a Drug?, MOTHER JONES, Aug. 18, 2014, http://www.motherjones.com/environment/2014/ 08/fecal-transplant-fda-openbiome-rebiotix (accessed June 18, 2015)
-
(2014)
MOTHER JONES
-
-
Park, A.1
-
39
-
-
84977632628
-
-
(accessed June 18, 2015)
-
Food & Drug Administration, Unapproved Drugs Initiative, 2014, http://www.fda.gov/Drugs/Guidance-ComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionson-UnapprovedDrugs/ucm118990.htm (accessed June 18, 2015)
-
(2014)
Unapproved Drugs Initiative
-
-
-
40
-
-
85054991415
-
KV Lawsuit Involving Makena and Compounded 17P Concludes in Sopranos Style
-
July 7 (accessed June 18, 2015)
-
Kurt R. Karst, KV Lawsuit Involving Makena and Compounded 17P Concludes in Sopranos Style, FDA LAW BLOG, July 7, 2014, http://www.fdalawblog.net/fda law blog hyman phelps/2014/07/ kv-lawsuit-involving-makena-and-compounded-17p-concludes-in-sopranos-style.html (accessed June 18, 2015)
-
(2014)
FDA LAW BLOG
-
-
Karst, K.R.1
-
41
-
-
85054953969
-
-
accessed June 18, 2015
-
http://prescriptions.blogs.nytimes.com/2011/05/31/ the-hidden-price-of-drugs/ (accessed June 18, 2015)
-
-
-
-
42
-
-
85054998607
-
-
accessed June 18, 2015
-
http://www.youtube.com/watch?v=xLIndT7fuGo (accessed June 18, 2015)
-
-
-
-
43
-
-
85054994046
-
-
accessed June 18, 2015
-
http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/ QuestionsaboutTissues/ucm102842.htm (accessed June 18, 2015)
-
-
-
-
44
-
-
84866738529
-
Transfer of IntestinalMicrobiota From LeanDonors Increases Insulin Sensitivity in Individuals WithMetabolic Syndrome
-
Anne Vrieze et al., Transfer of IntestinalMicrobiota From LeanDonors Increases Insulin Sensitivity in Individuals WithMetabolic Syndrome, 143 GASTROENTEROLOGY 913, 913 (2012)
-
(2012)
GASTROENTEROLOGY
, vol.143
, pp. 913-913
-
-
Vrieze, A.1
-
45
-
-
84881557235
-
The Adoptive Transfer of Behavioral Phenotype Via the Intestinal Microbiota: Experimental Evidence and Clinical Implications
-
Stephen M. Collins et al., The Adoptive Transfer of Behavioral Phenotype Via the Intestinal Microbiota: Experimental Evidence and Clinical Implications, 16CURR. OP. MICROBIOL. 240, 240 (2013)
-
(2013)
CURR. OP. MICROBIOL
, vol.16
, pp. 240-240
-
-
Collins, S.M.1
-
48
-
-
0024396816
-
Hematopoietic Reconstitution in a Patient with Fanconi's Anemia by Means of Umbilical-Cord Blood from an HLA-Identical Sibling
-
Eliane Gluckman et al., Hematopoietic Reconstitution in a Patient with Fanconi's Anemia by Means of Umbilical-Cord Blood from an HLA-Identical Sibling, 321 NEW ENG. J. MED. 1174, 1174 (1989)
-
(1989)
NEW ENG. J. MED
, vol.321
, pp. 1174-1174
-
-
Gluckman, E.1
-
49
-
-
0032008904
-
Blood As A Biological 'Drug': Scientific, Legal, and Policy Issues in the Regulation of Placental and Umbilical Cord Stem Cell Transplantation
-
Jennifer Kulynych, Blood As A Biological 'Drug': Scientific, Legal, and Policy Issues in the Regulation of Placental and Umbilical Cord Stem Cell Transplantation, 32U. RICH. L. REV. 407, 408 (1998)
-
(1998)
U. RICH. L. REV
, vol.32
, pp. 407-408
-
-
Kulynych, J.1
-
50
-
-
3142738671
-
Human Tissues and Reproductive Cloning: New Technologies Challenge FDA
-
Richard A. Merrill, Human Tissues and Reproductive Cloning: New Technologies Challenge FDA, 3 HOUS. J. HEALTH L. & POL'Y 1, 10 (2002)
-
(2002)
HOUS. J. HEALTH L. & POL'Y
, vol.3
, pp. 1-10
-
-
Merrill, R.A.1
-
51
-
-
85040105701
-
-
(accessed June 18, 2015)
-
Food & Drug Administration, Tissue Reference Group: FY 2012 Update, 2012, http://www.fda.gov/ biologicsbloodvaccines/tissuetissueproducts/regulationoftissues/ucm152857.htm (accessed June 18, 2015)
-
(2012)
Tissue Reference Group: FY 2012 Update
-
-
-
52
-
-
85054981377
-
-
accessed June 18, 2015
-
http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ UCM352902.pdf (accessed June 18, 2015)
-
-
-
-
53
-
-
85055006876
-
-
accessed June 18, 2015
-
http://www.gastro.org/ research/Joint Society FMT?Guidance.pdf (accessed June 18, 2015)
-
-
-
-
54
-
-
33646417326
-
Off-label Prescribing Among Office-Based Physicians
-
David C. Radley et al., Off-label Prescribing Among Office-Based Physicians, 166 ARCH. INTERN. MED. 1021, 1021 (2006)
-
(2006)
ARCH. INTERN. MED
, vol.166
, pp. 1021-1021
-
-
Radley, D.C.1
-
55
-
-
84878338805
-
The Continuum of Excludability and the Limits of Patents
-
Amy Kapczynski & Talha Syed, The Continuum of Excludability and the Limits of Patents, 122 YALE L. J. 1900 (2013)
-
(2013)
YALE L. J
, vol.122
, pp. 1900
-
-
Kapczynski, A.1
Syed, T.2
-
56
-
-
85054988395
-
-
(accessed June 18, 2015)
-
Seres Therapeutics, About Seres Therapeutics, 2015, http://serestherapeutics.com/about/about seres therapeutics/ (accessed June 18, 2015)
-
(2015)
About Seres Therapeutics
-
-
-
57
-
-
85040105701
-
-
(accessed June 18, 2015)
-
Food & Drug Administration, Tissue Reference Group: FY 2012 Update, 2012, http://www.fda.gov/ biologicsbloodvaccines/tissuetissueproducts/regulationoftissues/ucm152857.htm (accessed June 18, 2015)
-
(2012)
Tissue Reference Group: FY 2012 Update
-
-
-
58
-
-
85054989581
-
-
(accessed June 18, 2015)
-
Food & Drug Administration, Drug Shortage Management, 12, 2014, http://www.fda.gov/downloads/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/ UCM079936.pdf (accessed June 18, 2015)
-
(2014)
Drug Shortage Management
, vol.12
-
-
-
59
-
-
84920718211
-
Old Statutes, New Problems
-
Jody Freeman & David B. Spence, Old Statutes, New Problems, 163 U. PA. L. REV. 1 (2014)
-
(2014)
U. PA. L. REV
, vol.163
, pp. 1
-
-
Freeman, J.1
Spence, D.B.2
|