Dear Dr. Roach • You wrote recently that thyroid medication is regulated to within 5 percent of the stated amount. Are there other drugs that are similarly regulated? Are generic manufacturers held to a different standard than the manufacturers of…
Standards Of 'narrow Therapeutic Use' Under Fda Review
Dr. keith Roach, St. Louis Post-Dispatch: Living
Tue, 12/12/2017 - 11:00pm
BING NEWS:
- FDA Puts Clinical Hold on Neumora’s Schizophrenia Drug Due to Preclinical Safety Signals
Following cases of convulsions in rabbits in a preclinical study, the FDA has placed a clinical hold on Neumora Therapeutics’ Phase I schizophrenia drug candidate NMRA-266.
04/15/2024 - 2:53 am | View Link - FDA OKs Phase 3b trial design for NurOwn in less advanced ALS
The FDA has agreed that the design of a Phase 3b trial is generally adequate to back a potential regulatory application for NurOwn for ALS.
04/10/2024 - 6:11 am | View Link - FDA to Review Barth Syndrome Treatment Elamipretide
Barth syndrome is a rare genetic disorder characterized by muscle weakness and heart abnormalities. The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for elamipretide ...
04/7/2024 - 1:00 pm | View Link - Three key decisions cell and gene therapy trial sponsors need to make early into drug development
Unlike other therapeutic spaces, this often requires genetic screening ... participant eligibility can narrow quickly and slow enrolment. As importantly, it is critical for sponsors to consider ...
04/2/2024 - 12:59 pm | View Link - FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer
In the efficacy analysis, PSA reductions of = 50% were observed in 36% of PSA evaluable patients. For RECIST evaluable patients, 20% met the criteria of a partial response, or tumor reduction in size ...
04/2/2024 - 11:29 am | View Link - More
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