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Guide on Pediatric Study Ethical Considerations

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Product...

New Regulatory Paradigm Needed for Device Software: FDA

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FDA concludes after ending a recent pilot program on software as a medical device that a new regulatory paradigm is needed to regu...

3 Biocon Biologics FDA-483s Posted

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FDA posts three Form FDA-483s issued to Indias Biocon Biologics following three on-site August inspections at the companys seven m...

OGD Director Choe Leaving FDA Next Month

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CDER Office of Generic Drugs director Sally Choe decides to leave FDA effective 10/8 to pursue opportunities outside the agency.

CDER Adds Cannabis Advisor in Directors Office

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Former New York cannabis programs director Norman Birenbaum joins CDERs Office of the Center Director as a senior public health ad...

Guide on Exclusions for Naloxone Distribution

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Federal Register notice: FDA makes available a final guidance entitled Exemption and Exclusion from Certain Requirements of the Dr...

Regulatory Review Period for Nurtec ODT

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Federal Register FDA determines for patent extension purposes the regulatory review period for Biohaven Pharmaceuticals migraine d...

Info Collection on Pediatric Device Survey

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Federal Register notice: FDA seeks comments on a new information collection involving a pediatric device survey.

Ex-FDAer Unger Explains FDA Medical Queries

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Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger says FDA is likely to expand its ...

Pediatric Trial Ethical Consideration Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children.