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Info on Condom Labeling Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a special controls guidance for natural rubber latex ...

CDER Drug Safety Board Discusses Risperdal Consta

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CDERs Drug Safety Oversight Board reviews reports of needle detachments occurring with Janssens antipsychotic Risperdal Consta.

FDA Approves Abbott Test for Chagas Disease

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FDA approves Abbotts ESA Chagas [Trypanosoma cruzi (E. coli, recombinant) antigen], the first in vitro enzyme strip assay for use ...

FDA Extends Review for Takeda Diabetes NDAs

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FDA extends by three months its review of Takeda Pharmaceutical NDAs for the investigational Type 2 diabetes therapy alogliptin, a...

No Surprise: FDA Revokes Avastin Breast Cancer Indication

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In an anticipated move, FDA issues a revocation order on a metastatic breast cancer indication for Genentechs Avastin (bevacizumab...

A Red-Letter Day for FDA and Me

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Washington commentator Robert F. Steeves congratulates commissioner Hamburg and FDA for apparently following his advice in conveni...

FDA Clears IntriCon Remote Cardiac Monitor

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FDA clears an IntriCon 510(k) for the Sirona Event and Holter Recorder, a second-generation cardiac diagnostic monitoring device.

FDA, Industry Getting Closer to MDUFA Reauthorization

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Industry negotiators say the number of outstanding issues to be resolved with FDA as part of MDUFA 3 reauthorization talks is decr...

Advisors Support Prevnar Approval

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FDA advisors vote to recommend that Pfizers Prevnar pneumonia vaccine is safe and effective for use in adults over age 50.

FDA Proposes Regs on Tobacco Product Brand Names

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Federal Register Proposed rule: FDA proposes to amend regulations to allow certain tobacco manufacturers to maintain a brand name ...