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Draft Guide on Modernizing Clinical Trial Designs

[ Price : $8.95]

FDA releases a new draft guidance that is intended to modernize clinical trial designs in oncology drug development.

Workshop on Human Skin Safety Testing for Topicals

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Federal Register notice: FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Product...

FDA Approves Alnylams Onpattro for Nerve Disease

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FDA approves an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease caused by here...

FDA Proposes New Drug Promotion Study on Disclosures

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Federal Register notice: FDA submits to OMB a new information collection study entitled Disclosures in Professional and Consumer P...

Long-term Contraceptive Ring Approved

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FDA approves a Population Council NDA for Annovera, first vaginal ring contraceptive that can be used for an entire year.

Spacelabs Healthcare Recalls Anesthesia Device

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Spacelabs Healthcare recalls the Arkon Anesthesia Delivery System due to the device going into a failed state, which causes the me...

Vyaire Medical Recalls AirLife Resuscitation Device

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Vyaire Medical recalls its AirLife Resuscitation Device due to a manufacturing error.

FDAers Find Increases in Tropical Disease Drug Development

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Writing in PLOS online journal, three FDA researchers find a significant increase in the development of new tropical disease drugs...

Drug Complex Innovative Designs Pilot Program

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FDA outlines its planned Complex Innovative Designs Pilot Meeting Program that is intended to advance the use of complex adaptive,...

Guide on Drug Dissolution Testing

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Federal Register notice: FDA makes available a guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release...