Results 81 to 90 of about 5,545,002 (288)
Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
PLoS ONE, 2016 Background Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence.
A. Kesselheim +8 more
semanticscholar +1 more source
Maraviroc: integration of a new antiretroviral drug class into clinical practice [PDF]
, 2008 Maraviroc (Pfizer's UK-427857, Selzentry or Celsentri outside the US) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire FDA and EMEA approval.
Vandekerckhove, Linos +2 more
core +2 more sources
National Board of Examinations Journal of Medical SciencesBackground: Clinical trials are conducted with a set of ethical standards, patient safety measures, and scientific scrutiny. Clinical Data Management Systems have evolved over time, shaped by historical milestones, technological advancement, and ...
Thrupthi D L +4 more
doaj +1 more source
Current OncologyMedical oncology is a rapidly evolving field, with new medications being discovered yearly, contributing to increased survival rates. However, accessing drugs in a timely manner can be challenging. In Quebec, Canada, a physician can prescribe an unlisted
Adam Miller +4 more
doaj +1 more source
FDA Approval of Drugs and Devices: Preemption of State Laws for “Parallel” Tort Claims [PDF]
, 2015 The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from ...
Boumil, Marcia
core
Perspectives in Clinical ResearchAim: Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases.
Urvashi Gupta +2 more
doaj +1 more source
Spotlight on ixazomib: Potential in the treatment of multiple myeloma [PDF]
, 2016 Despite the significant therapeutic advances achieved with proteasome inhibitors (PIs) such as bortezomib and carfilzomib in prolonging the survival of patients with multiple myeloma, the development of drug resistance, peripheral neuropathy, and ...
Azab, Abdel K +5 more
core +2 more sources
Is It Possible to Have Cheaper Drugs and Preserve the Incentive to Innovate: Reforming the Drug Approval Process According to Market Principles [PDF]
This paper argues that drugs are expensive not because of a lack of competition among research-based pharmaceutical companies, but because of a lack of competition in the drug approval process.
Corinne Sauer, Robert Sauer
core
Landmark Alzheimer’s drug approval confounds research community
Nature, 2021 Asher Mullard
semanticscholar +1 more source
Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process [PDF]
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods.
Adrian H. B. Gottschalk +3 more
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