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Home » Topics » Regulatory

Regulatory
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US FDA advises on prostate cancer drugs, Canadian imports

May 27, 2022
Among the latest guidances pouring out from the U.S. FDA are ones addressing development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada.
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Drug capsules in petri dish

EMA tackles AMR with revised guidance

May 27, 2022
By Mari Serebrov
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
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Regulatory actions for May 27, 2022

May 27, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance, Nanomix.
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Sun sets on US HHS SUNSET Rule

May 27, 2022
By Mari Serebrov
A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day.
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Regulatory actions for May 27, 2022

May 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier.
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Petition to FDA raises questions about tests for DBS devices for Parkinson’s disease

May 26, 2022
By Mark McCarty
The U.S. FDA has received a citizen’s petition regarding the use of neuropsychological testing prior to placement of a deep brain stimulation (DBS) device for treatment of Parkinson’s disease. The petitioners, most of whose names were redacted, said that there is no standardized test for this purpose, and thus the patient should have sole discretion of evaluating the meaning of their own tests or the use of these tests should not be seen dispositive of the question of whether to go ahead with placement of a DBS device for Parkinson’s.
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Another U.S. opioid trial ends in settlement

May 26, 2022
By Mari Serebrov
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
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Microscope

Steps taken to move US advanced research agency from concept to reality

May 26, 2022
By Mari Serebrov
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH.
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Regulatory actions for May 26, 2022

May 26, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lumiradx, Nexus Medical Labs, Rhinostics.
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Regulatory actions for May 26, 2022

May 26, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Cornerstone, Elevation, Jaguar, Medac, Medexus, Oncotelic, Phathom, Verrica.
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