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Sponsors should conduct pediatric clinical trials as a means to both advance medical knowledge and avoid having products designated as misbranded, according to an expert.
When planning a clinical trial, sponsors expect the predictable challenges, such as slow enrollment, institutional review board (IRB) issues, and contract and personnel changes.
In light of rapidly expanding development costs and mounting drug-safety concerns, pharmaceutical companies are placing increased emphasis on their clinical trial activities. Drugmakers are targeting a number of issues on the clinical front, including managing trial-related disasters, addressing potential misbranding problems and improving their adverse event reporting activities. Sponsors are also seeking to accelerate development times by enhancing their relationships with investigators and contract research organizations, as well as by directing more resources toward pharmacogenetics and other advanced development strategies. This issue of FDL examines some of the best practices that drug firms can use to achieve these goals.
The Office of Human Research Protections (OHRP) needs to issue more definitive guidance about alternative models for institutional review board (IRB) review that explicitly divides responsibility between local and central review boards, according to clinical research stakeholders.
The FDA has warned a Dallas, Texas-based manufacturer to stop marketing its skin cream and aerosol sprays as treatments and cures against infections from anthrax and other pathogens.
OTC drugmaker Molecular Biologics (MBI) has signed a consent decree with the FDA requiring it to cease manufacturing and distributing its drug products until it can resolve repeated manufacturing violations at its Benicia, Calif., plant.
The European Commission has approved Teva Pharmaceutical's bid to buy U.S. drug firm Ivax for $7.4 billion, bringing Teva one step closer to reclaiming its title as the world's largest generic drugmaker.
U.S.-based generic firms Mylan Laboratories and Barr Laboratories have a leg up in the race to win a sublicense for Roche's highly sought-after antiviral Tamiflu, according to a recent Banc of America Securities report.
Par Pharmaceutical's wholly owned subsidiary Kali Laboratories has received final FDA approval for its abbreviated new drug application (ANDA) for ondansetron HCl orally disintegrating tablets (ODT) in 4- and 8-mg dosage strengths.
Wellbutrin XL manufacturer Biovail may have to face generic competition for the extended-release antidepressant sooner than expected, after one generic challenger being sued by Biovail filed a motion for summary judgment.