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1-176 out of 176 article(s)
Title Author Type Date Words
Expanded Access and Right to Try: Access to Investigational Drugs. Bodie, Agata Report Mar 1, 2021 8810
4D Pharma Reports Positive Results From Bowel Syndrome Treatment Trial. Oct 7, 2020 274
Holding clinical trials for COVID vaccine guarantees access to PH but... Sep 9, 2020 703
IATF approves rules on COVID-19 vaccine trials. Sep 7, 2020 618
DOH stops Cavite vaccine trial pending approval. Sep 3, 2020 458
House thanks senators for allowing congressmen's initiative to waive Phase 4 clinical trial for COVID-19 drugs. Aug 22, 2020 429
FDA: No one has applied for COVID-19 vaccine clinical trials. Aug 21, 2020 513
Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines. Ward, Erin H. Jun 1, 2020 2253
Vaccine on Fast Track but Still Needs Time. May 1, 2020 167
Cabinet approves draft law governing clinical trials in Egypt. Egypt Today staff Dec 26, 2019 270
Clinical trial draft law discussed by Parliament. Feb 21, 2019 404
Clinical research must be part and parcel of public health system (minister). Feb 7, 2019 192
Updated Common Rule: Key Changes for Research Using Stored Biospecimens. Sarata, Amanda K. Dec 1, 2018 1690
Fitting Track and Trace into a Patient-First Culture. Nov 12, 2018 1077
Right to Try: Access to Investigational Drugs. Thaul, Susan Nov 1, 2018 8533
Cochrane - A sinking ship? Oct 15, 2018 2106
Parliament to review controversial clinical trials draft law. Oct 9, 2018 156
Al-Sisi expresses objection regarding some articles of clinical trials' draft law. Oct 3, 2018 311
REGULATING MEDICINE UNDER A 'NO DEAL' BREXIT. Oct 1, 2018 315
We were shocked by position of higher education, former health ministers in Clinical Trial Law: MP Mostafa Kamal El-Din Hussein. Jul 31, 2018 1751
Eisai to Give Oral Presentation on Results of Phase III Head-to-Head Clinical Study of Lemborexant in Insomnia Disorder. Clinical report Jul 2, 2018 509
What the contract does not say ... A current analysis of what's missing in clinical trial agreements. Agar, G.; Burgess, L.J. Jul 1, 2018 3447
Egyptian Parliament approves controversial clinical trials law. May 13, 2018 305
How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Dabrowska, Agata; Thaul, Susan May 1, 2018 13886
What you need to know about Egypt's Clinical Trials Law. Apr 30, 2018 702
Do Dying Patients Have a Right to Experimental Treatments? Casey, Donna M.; Sawyer, Danielle M. Report Mar 1, 2018 1538
A CLINICAL STUDY OF ONLAY-INLAY MESH IN INDIRECT INGUINAL HERNIAS. Sreedhar, Sriramoju; Nynasindhu, Akula; Mukteshwar, Dasari Report Jan 29, 2018 4841
WHEN THE VULNERABLE BECOME EXPOSED: ANALYZING THE LEGAL AND ETHICAL IMPLICATIONS OF INCIDENTAL FINDING DISCLOSURE FOR CLINICAL TRIAL PARTICIPANTS, THE RISK TO INSURANCE COVERAGE, AND THE THREATS AND BENEFITS OF CLOUD-BASED ELECTRONIC HEALTH RECORDS. Desko, Colin Jan 1, 2018 18911
EUTOXRISK. Graepel, Rabea; Daneshian, Mardas Jan 1, 2018 775
Using Competencies to Transform Clinical Research Job Classifications. Brouwer, Rebecca Namenek; Deeter, Christine; Hannah, Deborah; Ainsworth, Terry; Mullen, Catherine; H Sep 22, 2017 4617
USA: bill requiring reporting of animal species and numbers used by federal agencies introduced. Brief article Jun 22, 2017 176
Why we need more sharing of clinical trial data. Wehbe, Sam May 1, 2017 1022
A Review on: Phase '0' Clinical Trials or Exploratory Investigational New Drug/Klinik Faz '0' Testleri ya da Yeni Ilac Kesif Arastirmalari Uzerine Bir Derleme. Gawai, Ashish A.; Gadekar, Faisal Shaikh, Mangesh; Deokar, Nitin; Kolhe, Shivanand; Biyani, K.R. Report Apr 1, 2017 3621
The Impact Of A Developing Regulatory Framework Governing LDTS In Precision Oncology: Re-Envisioning The Clinical Risk Assessment Paradigm. Drabiak, Katherine Mar 22, 2017 34076
Patient Consent and the Commercialization of Lab Data. Tanner, Adam Feb 1, 2017 1606
Non-clinical studies in the process of new drug Development--Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Andrade, E.L.; Bento, A.F.; Cavalli, J.; Oliveira, S.K.; Schwanke, R.C.; Siqueira, J.M.; Freitas, C. Report Dec 1, 2016 15656
Regulations require more transparent reporting of clinical trial results. Twachtman, Gregory Nov 1, 2016 473
Human trials of DNA-based Zika vaccine get underway. McKnight, Whitney Nov 1, 2016 454
U.S. government wants more transparent reporting of clinical trial data. Twachtman, Gregory Oct 15, 2016 518
Feds require more transparent reporting of clinical trial results. Twachtman, Gregory Oct 1, 2016 515
Reaction following Honey Rose trial. Brief article Sep 1, 2016 218
The data liberation movement: regulation of clinical trial data sharing in the European Union and the United States. Westergren, Amy Jun 22, 2016 9798
Court cases involving patent disputes on the rise. May 16, 2016 372
But is this really the 'parent' or 'guardian'? Practical strategies for consent to child research in South Africa. Slack, C.M.; Clin, M.A.; Strode, A.E. May 1, 2016 2620
Ethical considerations in implementing a biometric co-enrolment prevention system in clinical trials in South Africa. Moodley, J.; Naidoo, S.; Morar, N.S.; Govender, V.; Charls, P.; Ramjee, G. May 1, 2016 2311
Spotlight on clinical trial sponsorship. Mounce, Doug; Curci, Frank X.; Fortenbery, Joshua B. Mar 22, 2016 4154
Mastering Clinical Trial Documents 2016: Being Ready for Regulation Inspections. Feb 17, 2016 467
MHRA to Discuss Impact of New Clinical Trials Regulation on Industry. Feb 4, 2016 429
Should terminal patients be allowed to try experimental drugs? "Right to Try" laws offer hope for people trying to save their own lives. Manning, Alex Jan 1, 2016 647
Trust but verify, indeed. Nov 1, 2015 150
Licensed Drug Manufacturers should be controlled, monitored through Drugs Act and DRAP. Oct 15, 2015 845
The challenges of pharmaceutical labeling for clinical trials: new regulatory efforts are placing greater strain on clinical trials and the associated labeling required during this process. Bennett, John Oct 1, 2015 1020
OT student rep, Karan Vyas, discusses the college of optometrists' clinical guidelines. Vyas, Karan Brief article May 2, 2015 318
Despite requirement, only 13% of trial results reported. Moon, Mary Ann Apr 1, 2015 500
Challenging dangerous drugs & devices. Jan 1, 2015 353
Feds call for more transparency in reporting on trials. Twachtman, Gregory Jan 1, 2015 352
Rule aims to clarify clinical trial registry. Dec 8, 2014 125
HPV vaccination not responsible for deaths of six girls in India but research ethics criticised and litigation recommended for greater accountability in clinical trials. Brief article Nov 1, 2014 354
AABB comments on the FDA's draft guidance on considerations for early phase clinical trials for cellular therapy products. Cassata, Rafael K. Oct 1, 2014 954
Group questions safety of Rx trials. Brief article Aug 11, 2014 192
Tekmira Pharmaceuticals meets regulatory requirements to commence Phase I/II clinical trial of TKM-PLK1. May 29, 2014 139
Tekmira Pharmaceuticals meets regulatory requirements to commence Phase I/II clinical trial of TKM-PLK1. May 29, 2014 135
Using adaptive trial design to get ahead of tougher regulations: an outline of how adaptive clinical trial design could help medical device firms stay competitive in the face of more stringent European regulatory requirements. Spiess, Laurent; Zippel, Erdmann May 1, 2014 1988
Adapt to survive: adaptive clinical trial design could help medical device firms compete in the face of more stringent European regulatory requirements. Spiess, Laurent; Zippel, Erdmann May 1, 2014 1708
Establishing a data monitoring committee for clinical trials. Lin, Julia Y.; Lu, Ying Feb 1, 2014 2179
HEALTH : PROVISIONAL DEAL REACHED ON CLINICAL TRIALS REGULATION. Jan 24, 2014 434
HEALTH : PROVISIONAL DEAL REACHED ON CLINICAL TRIALS REGULATION. Jan 8, 2014 434
Clinical trial registration in the Eastern Mediterranean Region. John, Lisha Jenny; Muttappallymyalil, Jayakumary Jan 1, 2014 1585
Faster, stronger, smarter: considering the dietary supplement regulatory and litigation landscape. Wilensky, Saul; Kelly, Matthew J., Jr. Oct 1, 2013 6344
The South African clinical trial industry: implications of problems with the issuing of human tissue export permits. Burgess, L.J.; Pretorius, D. Jun 1, 2013 1892
In the interest of disclosure: FDA updates guidance on financial disclosures by clinical investigators. Heisey, Colleen Apr 1, 2013 1823
Implementing health reform: boosting clinical trial participation. Schneider, Mary Ellen Interview Feb 15, 2013 809
Implementing health reform: Boosting clinical trial participation. Feb 15, 2013 717
Government says no to fresh clinical trials. Jan 13, 2013 246
Fixing a broken drug development process. Holland, John Jan 1, 2013 936
CLINICAL TRIALS : PROPOSAL ALREADY A COMPROMISE, SAYS EFPIA. Oct 5, 2012 284
CLINICAL TRIALS : PROPOSAL ALREADY A COMPROMISE, SAYS EFPIA. Sep 26, 2012 287
Global Green Inc to commence advance trial of Salmogenics upon FDA's mandatory new regulation to promote Salmonella-Free egg. Aug 9, 2012 188
Global Green Inc to commence advance trial of Salmogenics upon FDA's mandatory new regulation to promote Salmonella-Free egg. Aug 9, 2012 184
MEDICINES : COMMISSION AIMS TO IMPROVE CLINICAL RESEARCH. Jul 20, 2012 577
MEDICINES : COMMISSION AIMS TO BOOST CLINICAL RESEARCH. Jul 18, 2012 577
HEALTH : CLINICAL TRIALS: PROPOSAL FOR A REGULATION PLANNED FOR JULY. May 25, 2012 244
HEALTH : CLINICAL TRIALS: PROPOSAL FOR A REGULATION PLANNED FOR JULY. May 16, 2012 244
DSM Board approves enrolment of more patients in ACT's macular degeneration trials. Oct 10, 2011 726
HHS proposes revamping clinical trial rules. Schneider, Mary Ellen Aug 1, 2011 458
Proprietary drug name approval: taking the duel out of the dual agency process. Clarke, Deirdre A. Mar 22, 2011 13785
The case for legal regulation of physicians' off-label prescribing. Rosoff, Philip M.; Coleman, Doriane Lambelet Mar 1, 2011 20135
The regulation of informed consent to participation in clinical research by mentally ill persons in South Africa: an overview. Nienaber, A. Report Dec 1, 2010 4817
New rules for clinical trials. Oct 25, 2010 550
New safety reporting requirements. Brief article Oct 15, 2010 295
Type I terrors: a risk-averse FDA is not good for Americans' health. Miller, Henry I. Sep 22, 2010 3142
What do FTC's Consent Decrees mean for research? Conducting clinical studies is not as burdensome as you think. Kalman, Douglas Sep 1, 2010 775
Misplaced trust? Gaping flaws in drug approval and licensing. Ncayiyana, Daniel J. Editorial Jul 1, 2010 831
A Pan-African Clinical Trials Registry for the specific needs of triallists on the continent. Abrams, Amber; Siegfried, Nandi Editorial May 1, 2010 973
Clinical trial disclosure: a medtech software expert provides proven technology strategies for manufacturers. Tadikonda, Satish Nov 1, 2009 1162
The public's right to health: when patient rights threaten the commons. Leonard, Elizabeth Weeks Oct 1, 2009 31626
Rules for access to Rxs under development set. Sep 28, 2009 408
Patient negligence. Goodwin, Michele; Richardson, L. Song Sep 22, 2009 13600
A longer monopoly for biologics? Considering the implications of data exclusivity as a tool for innovation policy. Sorscher, Sarah Sep 22, 2009 12107
FDA expands access to investigational drugs. McNamara, Damian Sep 15, 2009 327
Clinical trials go global: next stop, Latin America. Chin, Richard; Safar, Libor Jul 1, 2009 2551
Is marketing the enemy of pharmaceutical innovation? Applbaum, Kalman Jul 1, 2009 3918
In the know: drug trial basics. Mofitt, Kevin Jun 22, 2009 496
India bolsters trial ethics code: stricter laws are in the cards, and concerns remain. Harachand, S. Jun 1, 2009 851
The FDA and Helsinki. Rennie, Stuart May 1, 2009 662
The race for global clinical trials: how strong are trial regulations in developing regions? Silverman, Ed Apr 1, 2009 1418
Dying to wait: how the Abigail court got it wrong. Tovanche, Juan Joel Mar 22, 2009 19290
Expanding access to investigational drugs for treatment use: a policy analysis and legislative proposal. Winniford, Austin Jan 1, 2009 18198
The Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture in intellectual property; rethinking the role of clinical trial data in international intellectual property law: the case for a public goods approach. Reichman, Jerome H. Jan 1, 2009 30343
Supreme Court rules that FDA approval of the safety risks listed on a medication's label does not immunize manufacturers from state tort claims for a failure to warn of other dangers from ingesting the medication. Hafemeister, Thomas L. Jan 1, 2009 2131
'Relax rules on clinical trials or patients will lose out to US' Research stifled, says professor. Oct 20, 2008 544
Ethical perspectives of children's assent for research participation: deontology and utilitarianism. Pieper, Pam Jul 1, 2008 3578
Canadian legal oversight of pharmacogenomics and nutrigenomics. Morin, Karine Jun 22, 2008 6944
Sustaining public trust: falling short in the protection of human research participants. Mastroianni, Anna C. May 1, 2008 1721
Clinical trial reimbursement integration and management. Schneider, Charles E. May 1, 2008 1384
U.K. moves to augment drug safety legislation. Brief article Apr 28, 2008 205
The rationale for a registry of clinical trials involving human stem cell therapies. Isasi, Rosario M.; Nguyen, Thu Minh Mar 22, 2008 8007
Case two: a Kantian approach to the morality of blood substitute clinical trials without informed consent. Fields, Keota Mar 22, 2008 1058
Hugs and drugs: research ethics, conflict of interest, and why the FDA's attempt to preempt pharma failure-to-warn claims is a dangerous prescription. Martin, Christina Marie Mar 22, 2008 16616
Trials and tribulations. Gilbert, Susan Mar 1, 2008 3492
Research in the physician's office: navigating the ethical minefield. Snyder, Lois; Mueller, Paul S. Mar 1, 2008 1906
Eight years after Jesse's death, are human research subjects any safer? Gelsinger, Paul; Shamoo, Adil E. Mar 1, 2008 1417
FDA regulation of labels on medications preempts "failure-to-warn" lawsuits asserting that manufacturers of SSRIs failed to adequately warn of a risk of suicide purportedly associated with these medications. Hafemeister, Thomas L. Jan 1, 2008 1932
Un-informed consent: the United Nation's failure to appropriately police clinical trials in developing nations. McGregor, Molly Dec 22, 2007 10407
Data on elderly glossed over. Matthews, Renee Brief article Dec 1, 2007 191
MEDICINES : HEADING TOWARDS CHANGES IN THE CLINICAL TRIAL DIRECTIVE. Oct 8, 2007 788
Somewhere to run, somewhere to hide? International regulation of human subject experimentation. Laughton, Adam H. Sep 22, 2007 12697
Overcome the pain of drug accountability: Nikki Dowlman, Product Manager, ClinPhone, and Paul McPhillips, founder and partner, BioLogic LLP, explore the minefield that is drug accountability in clinical trials. Dowlman, Nikki; McPhillips, Paul Sep 1, 2007 2444
DEVELOPMENT : REPORT CRITICAL OF HANDLING OF FLAGSHIP INITIATIVE ON HIV. Jul 19, 2007 473
Medicare proposes policy revisions for clinical trials. Lesney, Mark S. Brief article Jun 1, 2007 195
Paediatric regulation enters force. Smith, Reed Brief article May 1, 2007 303
Revisions to UK model clinical trial agreement. Smith, Reed May 1, 2007 521
FDA will ease access to experimental drugs. Jan 22, 2007 352
Prospects bright for pediatric drug development: recent efforts are changing a landscape that lacks clinical trials targeting children and adolescents. Brunk, Doug Jan 1, 2007 818
Technology unbound: will funded libertarianism dominate the future? Goldberg, Steven Jan 1, 2007 5944
Regulation of stem cell-based products. von Tigerstrom, Barbara; Schroh, Erin Jan 1, 2007 17003
Minimal risk in the Tri-Council policy statement. Reid, Lynette; Krahn, Timothy Jan 1, 2007 17964
Panel opposes separate drug testing in the elderly. MacNeil, Jane Salodof Nov 1, 2006 618
An open door to ending exploitation: accountability for violations of informed consent under the Alien Tort Statute. Talati, Erin Nov 1, 2006 21073
Prospects bright for pediatric drug development. Brunk, Doug Sep 1, 2006 681
Clinical trial participation. Nickell, Nancy Brief article Aug 1, 2006 169
Transparency and innuendo: an alternative to reactive over-disclosure. Lassman, Scott M. Jun 22, 2006 7315
Sometimes the silence can be like the thunder: access to pharmaceutical data at the FDA. Lurie, Peter; Zieve, Allison Jun 22, 2006 5207
Blood-substitute tests proceed without informed consent. Burtka, Allison Torres Jun 1, 2006 960
Clinical trials come in for scrutiny. Brief article May 1, 2006 243
Voice of Experience. Waugaman, Paul G. Column May 1, 2006 2230
FDA guidance backs early clinical studies. Schneider, Mary Ellen Mar 1, 2006 597
FDA moves to facilitate R&D. Feb 27, 2006 613
New FDA guidance allows small studies in humans before phase I safety testing. Schneider, Mary Ellen Feb 15, 2006 579
Patterns of trial registration. Lubell, Jennifer Brief Article Feb 1, 2006 221
Clinical trials. Brief Article Aug 29, 2005 212
Companies still hiding drug trial data, medical journals say. Jurand, Sara Hoffman Aug 1, 2005 876
A new era in drug regulation? Dresser, Rebecca May 1, 2005 1672
Federal regulation of REB review of clinical trials: a modest but easy step towards an accountable REB review structure in Canada. Lemmens, Trudo Mar 22, 2005 8525
What works? Roberts, Helen Mar 1, 2005 8692
Big pharma's annum horribilis. Feb 1, 2005 464
TRIALS AND TRIBULATIONS FOR NEW MEDICINES. Jan 8, 2005 368
PHARMACEUTICALS:INDUSTRY OPENS UP MORE ON CLINICAL TRIALS. Jan 8, 2005 340
Unethical contraceptive trial in India. Brief Article Nov 1, 2004 126
Pushing for clinical trial registration. Silverman, Jennifer Oct 1, 2004 1044
PhRMA develops guidelines on how to conduct clinical trials. Aug 30, 2004 375
Cambodia stops important tenofovir prevention trial. James, John S. Jul 23, 2004 1029
Clinical trials: the new frontier in fraud: huge dollars at stake. Frieden, Joyce Jan 15, 2004 899
MEDICINES: NEW EU RULES SHED LIGHT ON SECTOR'S PROBLEMS. May 21, 2003 387
PHARMACEUTICALS: INDUSTRY EXPRESSES CONCERN ABOUT CLINICAL TRIALS RULES. Dec 4, 2002 311
MEDICINES: CONCERN OVER EU CLINICAL TRIALS RULES. (European Union). Brief Article Sep 10, 2002 495
Single-trial drug approvals. (Guest Editorial). Peck, Carl C. Brief Article Mar 15, 2002 670
Are medical product clinical trials conducted outside the US worth being concerned about? (FDA Update). Anast, David G. Brief Article Nov 1, 2001 817
Arizona's Cancer Clinical Trials Law: Flawed Process, Flawed Product. OLSON-GAREWAL, J. KRISTIN; HESSLER, KRISTEN May 1, 2001 2104
HEALTH COUNCIL: EU MINISTERS OPT FOR STRICT RULES ON MEDICINES AND CJD. Brief Article Dec 16, 2000 745
MEDICINES: CLINICAL TRIALS COMPROMISE WINS EUROPEAN PARLIAMENT BACKING. Brief Article Dec 16, 2000 641
Lessons taught by Miss Evers' Boys: the inadequacy of benevolence and the need for legal protection of human subjects in medical research. Hermann, Donald H.J. Jun 22, 2000 8749
Protection of human subjects in research questioned. Sep 22, 1998 618
Can science survive research by quota? Satel, Sally L. Sep 1, 1995 1890
FDA's compassion for desperate drug companies. Annas, George J. Jan 1, 1990 2718
Proposal seeks wider access to AIDS drugs. Fackelmann, K.A. Jul 1, 1989 403

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