Results 241 to 250 of about 159,613 (271)

Reinforcing the social compromise of accelerated approval

Nature Reviews Clinical Oncology, 2018
Accelerated approval enables investigational drugs to reach the US market on the basis of their demonstrated effects in unvalidated surrogate measures, only reasonably likely to predict clinical response. To fulfil the social compromise, regulators should ensure that confirmatory trials testing clinically meaningful end points are already underway at ...
Bishal Gyawali, Aaron S. Kesselheim
openaire   +2 more sources

The Accelerated Approval of Oncologic Drugs

JAMA, 2014
On October 31, 2013, the US Food and Drug Administration (FDA) suspended marketing and sales of the BCR-ABL tyrosine kinase inhibitor ponatinib (Iclusig, Ariad Pharmaceuticals). Just 7 weeks later, on December 20, 2013, the FDA partially reversed that decision, permitting use of the drug under a narrower indication.
Vinay, Prasad, Sham, Mailankody
openaire   +2 more sources

Surrogate Endpoints And FDA’s Accelerated Approval Process

Health Affairs, 2005
There is interest in approaches allowing more rapid availability of new interventions, particularly for diseases providing risks of death or serious illness. The accelerated-approval regulatory process is intended to address this need by allowing marketing of interventions shown to have strong effects on measures of biological activity, if those ...
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Accelerated Approval Is Not Conditional Approval

JAMA Oncology, 2022
Gautam U, Mehta, R Angelo, de Claro, Richard, Pazdur   +2 more
openaire   +2 more sources

Surrogate markers accelerate antiviral approval

Inpharma Weekly, 1994
In an effort to accelerate the regulatory approval of novel anti-HIV drugs, surrogate markers are being used in place of clinical endpoints. These markers can be used to identify pharmacological effects or to predict the possible future benefit of new approaches to therapy.
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Collateral damage from accelerated drug approval

Nature, 2023
Akihiko, Ozaki, Kenji, Gonda, Yudai, Kaneda, Tetsuya, Tanimoto   +3 more
openaire   +2 more sources

Testimony on accelerated approval.

GMHC treatment issues : the Gay Men's Health Crisis newsletter of experimental AIDS therapies, 2004
In 1994, Carlton Hogan testified before an FDA Antiviral Advisory Committee about the risks of letting drugs loose in the population without a rigorous method to detect and report late emerging toxicity. In 2003, AIDS activists met with FDA and repeated many of the concerns that Hogan outlined: the need for post-marketing follow-up, the failure of drug
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Conflicting signals on US accelerated approvals

Nature Biotechnology, 2005
While the FDA waits for someone to come up with a plan to improve the accelerated approval program, some argue that as it is, drugs are not getting to the people who need them.
openaire   +1 more source

Balancing Accelerated Approval for Drugs With Accelerated Withdrawal

JAMA Internal Medicine, 2016
Alain, Braillon, David B, Menkes
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RAC Approves Accelerated Review!

Human Gene Therapy, 1994
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