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Oncologic Drugs Committee Renewed for 2 Years

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Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond th...

New Reimbursement Scheme for New Antibiotics Needed: FDA

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Severing FDAs historical independence from drug economics, commissioner Scott Gottlieb suggests that new innovative payment/reimbu...

Info Collection on Compounding Bulk Drug Substances

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Clinical Use of Bulk Drug Substances Nom...

PhRMA Supports Streamlined GMPs for Combo Products

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Pharmaceutical Research and Manufacturers of America says it supports FDAs efforts to identify alternative or streamlined mechanis...

Workshop on Patient Experiences in Clinical Trials

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FDA hosts a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to develop and identify...

DTC Drug Pricing Amendment Shot Down on Hill

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House Republicans derail a Trump-supported legislative measure that would have required drug companies to include prices in their ...

Workshop on Blood Pathogen Reduction Technologies

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Federal Register notice: FDA announces an 11/28 public workshop entitled Pathogen Reduction Technologies for Blood Safety.

Draft Guide on New ANDA Review Letters

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FDA issues a draft guidance on Information Requests and Discipline Review Letters Under GDUFA that outlines how such letters will ...

FDA Revises Listing of Drugs Needing Generic Competition

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FDA improves transparency in a revised listing that identifies brand drugs that do not have any generic competition.

FDA Guide on IVDs Used in Precision Medicine Development

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FDA releases a draft guidance on Investigational IVD Used in Clinical Investigations of Therapeutic Products to help researchers i...