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Workshop on Human Skin Safety Testing for Topicals
[100 Words]
[ Price : $8.95]
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| Federal Register notice: FDA announces a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” |
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08/10/2018
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FDA Approves Alnylam’s Onpattro for Nerve Disease
[406 Words]
[ Price : $8.95]
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| FDA approves an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis in adult patients. |
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08/10/2018
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FDA Proposes New Drug Promotion Study on Disclosures
[115 Words]
[ Price : $8.95]
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| Federal Register notice: FDA submits to OMB a new information collection study entitled “Disclosures in Professional and Consumer Prescription Drug Promotion” (OMB Control Number 0910-New). |
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08/10/2018
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Long-term Contraceptive Ring Approved
[113 Words]
[ Price : $8.95]
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| FDA approves a Population Council NDA for Annovera, first vaginal ring contraceptive that can be used for an entire year. |
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08/10/2018
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Spacelabs Healthcare Recalls Anesthesia Device
[102 Words]
[ Price : $8.95]
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| Spacelabs Healthcare recalls the Arkon Anesthesia Delivery System due to the device going into a “failed state,” which causes the mechanical ventilation function to stop working. |
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08/10/2018
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FDAers Find Increases in Tropical Disease Drug Development
[272 Words]
[ Price : $8.95]
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| Writing in PLOS online journal, three FDA researchers find a significant increase in the development of new tropical disease drugs after Congress enacted the priority review voucher legislation. |
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08/10/2018
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Drug Complex Innovative Designs Pilot Program
[160 Words]
[ Price : $8.95]
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| FDA outlines its planned “Complex Innovative Designs Pilot Meeting Program” that is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. |
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08/09/2018
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Guide on Drug Dissolution Testing
[78 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a guidance entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.” |
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08/09/2018
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