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FDA Approves Lumisight to Help Find Cancer

[ Price : $8.95]

FDA approves Lumicells Lumisight to assist in the detection of cancerous tissue in breast cancer patients undergoing a lumpectomy....

Priority Review Voucher to Orchard Therapeutics

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval...

Info Collection on Drug Expedited Programs

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Federal Register notice: FDA sends to OMB an information collection extension entitled Expedited Programs for Serious Conditions ...

New PMI Form Explained

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CDER Office of Medical Policy regulatory counsel Christopher Diamant explains why the new Patient Medication Information form was ...

SCOTUS Wont Hear False Labeling Case

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Two Polsinelli attorneys say the Supreme Courts refusal to hear an appeal in a labeling case helps manufacturers argue for preempt...

Woodcock Plays Advisory Role at Patient Nonprofit

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Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advis...

PhRMA Changes for Data Committee Guide

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PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.

Alecensa OKd for ALK-Positive Lung Cancer

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FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplasti...

3rd Eugia FDA-483 This Year So Far

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FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra...

Its Official: Oncopeptides Pepaxto is Withdrawn

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FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has bee...