2005 Update on Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies from the Research on Adverse Drug-Events and Reports (RADAR): Rate of Regular Approval Conversion Remains Low.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 289-289
Author(s):  
Charles L. Bennett ◽  
Jessica A. Zagory ◽  
June M. McKoy ◽  
Kathryn R. McCaffrey ◽  
E. Allison Lyons ◽  
...  
Keyword(s):  
Imatinib Mesylate ◽  
Adverse Drug Events ◽  
Hematologic Malignancies ◽  
Gemtuzumab Ozogamicin ◽  
Low Grade ◽  
Serious Adverse Events ◽  
New Drug ◽  
Drug Companies ◽  
Fda Approval ◽  
Post Marketing

Abstract Background: At ASH 2004 we reported that prior to 2004, eight drugs had received accelerated approval (AA) for ten hematologic oncology indications, only one had converted to full approval, and three serious adverse events associated with two of these drugs were identified post-approval. Following our presentation, Congressman Ed Markey (D-Massachussets) in June 2005 issued a report (“Conspiracy of Silence”) that raised similar concerns about the low rates of conversion from accelerated to regular approval and the failure of the FDA in ensuring that drug companies complete the required post-marketing studies. We update the experience with accelerated FDA approval for hematologic oncology. Methods: Information was obtained from the FDA on new drug applications and supplements for new uses, package inserts, and medical literature reviews. Results: Of 11 drug indications that received AA for hematologic oncology between 1995 and 2005, AA was generally granted for 9 based on clinical trials with <100 patients that identified high response rates. In the past year, none have applied for conversion to regular approval. Bortezomib received regular approval for an indication different than that granted for AA. Three serious adverse drug reactions were identified for two indications (gemtuzumab ozogamicin, imatinib for GIST) within 2 years of AA approval. Conclusion: Since 2004, one new drug received AA for a hematologic oncology indication, one drug received regular approval for an indication different from that indicated under AA, and although 1 more year has elapsed, conversion has yet to occur for nine AA hematologic oncology indications. It is imperative that the FDA establish clear milestones regarding conversion to regular approval at the time AA is granted. Drug Name (AA Date; Years Lapsed Since AA) AA Indication Years to AA/Regular Approval N in Trial (Overall Response Rate) *Regular approval granted for myeloma failing one treatment Denileukin difitox (2/99; 6.5) T-cell lymphoma 1.17/- 71 (30%) Cytarabine liposomal (4/99; 6.3) Lymphomatous meningitis 0.46/- 14 (71%) Gemtuzumab ozogamicin (5/00; 5.35) CD33 positive AML 0.58/- 142 (30%) Alemtuzumab (5/01; 4.3) CLL 1.375/- 93 (33%) Imatinib mesylate (5/01) CML 0.25/2 864 (80%) Ibritumomab tuixetan (2/02; 3.5) Low-grade NHL 1.3/- 157(68%) Imatinib mesylate (2/02; 3.5) GIST 0.29/- 147 (54%) Imatinib mesylate (12/02; 2.7) CML peds 0.5/- 39 (67%) Bortezomib (5/03) Multiple myeloma w/ 2 prior chemo treatments* 0.46/2 193 (35%) Tositumomab (6/03/2.2) NHL 4.0/- 59 (71%) Clofarabine (12/04; 0.7) Relapsed/refractory ALL peds 0.75/- 49 (20%)

Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies: Are Policy Changes Needed?.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 266-266 ◽  
Author(s):  
Elizabeth A. Lyons ◽  
June M. McKoy ◽  
Steven Belknap ◽  
Kenneth R. Carson ◽  
Charles L. Bennett
Keyword(s):  
Adverse Drug Reactions ◽  
Overall Response Rate ◽  
Response Rate ◽  
Surrogate Endpoint ◽  
Hematologic Malignancies ◽  
Drug Reactions ◽  
Fda Approval ◽  
Post Marketing ◽  
Accelerated Approval ◽  
Full Approval

Abstract Background: In 1992, the FDA extended the accelerated approval program from HIV and AIDs, to include drugs for other diseases that are serious or life-threatening, appear to provide benefit over available therapy, or for which no other therapy is available. Approval is based on a surrogate endpoint, and pharmaceutical companies are required to confirm safety and efficacy by conducting clinical trials with clinically relevant outcomes. Since 1995, eight drugs used to treat hematologic malignancies have received accelerated approval. Methods: Information available to the public under the Freedom of Information Act was surveyed for new drug applications and supplements for new uses approved by the Division of Oncology Products from January 1, 1995 to August 31, 2003. The package insert and corresponding published literature for the approval of each drug were reviewed for indication, time from drug submission to approval, surrogate endpoint, number of patients in trial, percent response and status of full approval. Results: Of the eight drugs which received accelerated FDA approval, approval was granted within 6 months for three (these also received priority review), 1 was approved within 6–12 months; and 4 were approved after 1 year of FDA review. Approvals were based on the surrogate clinical outcome of response rate. Pivotal studies were often small, with < 100 patients (n=3) and 100–250 patients (n=4). The overall response rate was < 33% for four drugs. Only one of the approvals has been converted to full approval (imatinib). Post-marketing studies have identified three potentially fatal adverse drug reactions related to two drugs (gemtuzumab associated veno-occlusive diesease, gemtuzumab associated severe infusion reactions and imatinib associated upper GI bleeds). Conclusion: To date, accelerated FDA approval for eight hematologic oncology drugs has been granted based on pivotal trials with small sample sizes and low response rates (with the exception of imatinib). Conversion to full approval has rarely occurred (N=1) and post-marketing identification of severe adverse drug reactions, in what were initially off-label settings, has occurred for two of the drugs. Modification of the accelerated approval process for hematologic oncology drugs should be considered. FDA approval information for accelerated approval drugs used to treat hematologic malignancies. Drug Name Indication Time to Approval (Months) N in Trial Overall Response Rate (%) Alemtuzumab CLL 16.5 93 33 Bortezomib Myeloma 3.7 188 14 Cytarabine liposomal Lymphomatous meningitis 5.5 17 41 Denileukin diftitox T-cell lymphoma 14 206 16 Gemtuzumab CD33 positive AML 7 142 26 Ibritumomab tiuxetan Low-grade NHL 15.6 157 62 Imatinib mesylate CML 3 1027 66 Tositumomab NHL 48 40 63

2006 RADAR Report Card on Conversion Rates from Accelerated FDA Approval to Regular FDA Approval for Drugs Used To Treat Hematologic Malignancies: Policy Changes Continue To Be Needed.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3318-3318
Author(s):  
Andrew J. Lurie ◽  
Mark V. Mai ◽  
Martin S. Tallman ◽  
June McCoy ◽  
Charles L. Bennett
Keyword(s):  
Imatinib Mesylate ◽  
Solid Tumors ◽  
Trial Design ◽  
Liposomal Doxorubicin ◽  
Hematologic Malignancies ◽  
Lymphocytic Leukemia ◽  
Current Status ◽  
Cancer Drugs ◽  
Fda Approval ◽  
Conversion Rates

Abstract Background: At ASH 2004 and 2005, we reported < 20% rates of from accelerated approval (AA) to regular approval (RA) for drugs used to treat hematologic malignancies (HMs). The FDA convened Oncologic Drug Advisory Committee (ODAC) meetings with sponsors of these drugs in 2003 and 2005 outlining recommendations for completion of subpart H trials. Congressmen Markey and Hinchey have raised concern over low rates of completion of subpart H studies for all AA drugs. The Research on Adverse Drug Events and Reports (RADAR) project reviewed the current status of subpart H commitments for all cancer drugs that received AA prior to 2005. Methods: NDAs and supplements for new uses from the FDA, package inserts, and literature reviews were reviewed. Results: Of 19 cancer drugs receiving AA prior to 2005, conversion to RA has occurred for 2 of 9 drugs for HMs and 8 of 11 drugs for solid tumors (STs) (22% vs 73%, p<0.05). Subpart H studies have been ongoing for a median of 5 years for AA drugs for HMs; however, for ST drugs, these studies were completed in a median of 2.5 years. Of 7 subpart H studies reviewed at the 2005 ODAC meeting on AA, subpart H evaluations continue for all 4 for HMs versus 1 of 3 for STs. HMs are characterized by lower rates of target populations, most having > 25,000 newly diagnosed patients annually (25% vs 78%). Recruitment targets are smaller for AA studies for HMs (median, 82 vs 295 patients) and subpart H studies (median, 295 vs 535). Conclusions: Rates of conversion from AA to RA remain poor for drugs for hematologic malignancies but not for solid tumors drugs. In spite of ODAC meetings and two congressional inquiries, little progress ahs been made towards completing these trials. RADAR continues to urge policy makers to modify the AA process for drugs used to treat hematologic malignancies. Hematologic malignancy drugs receiving AA prior to 2005 and current status of subpart studies Drug AA Indication Pts in AA trial design AA year Target # of pts in Subpart H study RA Year Imatinib mesylate CML 1027 2001 1027 2003 Bortezomib MM 202 2003 669 2005 Denileukin difitox* CTCL** 71 1999 195 Pending Liposomal cytarabine* Lymphomatous meningitis** 33 1999 195 Pending Gemtuzumab ozogamicin* AML** 142 2000 342 Pending Alemtuzumab* B-Cell Chronic lymphocytic leukemia** 93 2001 197 Pending Ibritumomab tiuxetan Certain NHLs ** 230 2002 293 Pending Imatinib mesylate CML (pedatrics)** 39 2003 35 Pending Tositumomab Certain NHLs** 60 2003 N/A Pending Solid tumor cancer drugs receiving AA prior to 2005 and current status of subpart studies Drug AA Indication Pts in AA trial design AA year Target # of pts in Subpart H study RA year * Recommendations for completing trials were made at recent ODAC meetings ** Indications with >25,000 new diagnosis annually Irinotecan Colorectal 304 1996 535 1998 Docetaxel Breast 134 1996 326 1998 Capecitabine Breast 163 1998 511 2001 Temozolomide Brain 162 1999 573 2005 Liposomal Doxorubicin* Ovarian 85 1999 474 2005 Oxaliplatin Colorectal 463 2002 795 2004 Anastrozole Breast 9366 2002 6196 2005 Gefitinib Lung 221 2003 1700 2005 Liposomal Doxorubicin* Kaposi’s sarcoma** 77 1995 250 Pending Amifostine Non-small cell lung** 25 1996 366 Withdrawn Imatinib mesylate GI stromal tumors** 147 2002 946 Pending

Drug Trials, Doctors, and Developing Countries: Toward a Legal Definition of Informed Consent

1996 ◽  
Vol 5 (3) ◽  
pp. 387-399 ◽  
Author(s):  
Adina M. Newman
Keyword(s):  
Clinical Stage ◽  
Drug Application ◽  
Research Process ◽  
New Drug ◽  
Third Phase ◽  
Drug Companies ◽  
Fda Approval ◽  
Definition Of ◽  
New Drug Application ◽  
To Receive

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc. (Maxwell), wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration (FDA). The new drug is expected to receive FDA approval in 2 or more years. The company decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs.

scholarly journals AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1150.1-1150
Author(s):  
T. Fujii ◽  
T. Atsumi ◽  
N. Okamoto ◽  
N. Takahashi ◽  
N. Tamura ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Aspiration Pneumonia ◽  
Japanese Patients ◽  
Research Support ◽  
Serious Adverse Events ◽  
Chugai Pharmaceutical ◽  
Post Marketing Surveillance ◽  
Otsuka Pharmaceutical ◽  
Post Marketing

Background:An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs.Objectives:To evaluate Bari safety in RA patients (pt) in clinical practice.Methods:We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020.Results:Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%.Conclusion:Data do not show new safety concerns and encourage guideline-compliant use of Bari.Disclosure of Interests:Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd.Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co.Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc.Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.

Thrombotic complications in adult patients with lymphoma: a meta-analysis of 29 independent cohorts including 18 018 patients and 1149 events

Blood ◽  
2010 ◽  
Vol 115 (26) ◽  
pp. 5322-5328 ◽  
Author(s):  
Vanesa Caruso ◽  
Augusto Di Castelnuovo ◽  
Susana Meschengieser ◽  
Maria A. Lazzari ◽  
Giovanni de Gaetano ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Meta Analysis ◽  
Hematologic Malignancies ◽  
Incidence Rates ◽  
Clinical Implications ◽  
Low Grade ◽  
Thrombotic Risk ◽  
Non Hodgkin Lymphoma ◽  
Thrombotic Complications ◽  
Exact Maximum Likelihood

AbstractThrombotic complications in hematologic malignancies have important clinical implications. In this meta-analysis we sought to obtain accurate estimates of the thrombotic risk in lymphoma patients. Articles were searched in electronic databases and references. Eighteen articles were identified (29 cohorts, 18 018 patients and 1149 events). Pooled incidence rates (IRs) were calculated by the use of a method based on the exact maximum likelihood binomial distribution. The global IR of thrombosis was 6.4% (95% confidence interval [CI] 6.0%-6.8%). The global IRs of venous or arterial events were 5.3% (95% CI, 5.0%-5.7%) and 1.1% (95% CI, 0.9%-1.2%), respectively. The IR of thrombosis observed in subjects with non-Hodgkin lymphoma (NHL) was 6.5% (95% CI, 6.1%-6.9%), significantly greater than that observed for patients with Hodgkin lymphoma (4.7%; 95% CI, 3.9%-5.6%). Within NHL, patients with high-grade disease had a greater risk of events (IR 8.3%; 95% CI, 7.0%-9.9%) than low-grade disease (IR 6.3%; 95% CI, 4.5%-8.9%). This meta-analysis shows that the IR of thrombosis in lymphoma patients is quite high, especially in those with NHL at an advanced stage of the disease. These results may help better defining lymphoma populations at high thrombotic risk, to whom prophylactic approaches could be preferentially applied.

scholarly journals An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

2021 ◽  
pp. 01-06
Author(s):  
Unnati Saxena ◽  
Debdipta Bose ◽  
Shruti Saha ◽  
Nithya J Gogtay ◽  
Urmila M Thatte
Keyword(s):  
Adverse Drug Events ◽  
The United States ◽  
Institutional Review Boards ◽  
Chi Square ◽  
Institutional Review ◽  
United States Food ◽  
Post Marketing ◽  
Chi Square Test ◽  
Us Fda ◽  
Review Boards

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

scholarly journals Tu1145 ENDOSCOPIC TRANSMISSION OF CARBEPENEM-RESISTANT ENTEROBACTERIACEAE: FDA APPROVAL AND POST-MARKETING SURVEILLANCE OF ENDOSCOPIC DEVICES

2020 ◽  
Vol 91 (6) ◽  
pp. AB564-AB565
Author(s):  
Nasir Saleem ◽  
Mohammad K. Ismail ◽  
Claudio Tombazzi ◽  
Sarthak Soin ◽  
Sanket S. Dhruva
Keyword(s):  
Fda Approval ◽  
Post Marketing Surveillance ◽  
Post Marketing
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