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List of Information Collections Approved by OMB

[ Price : $8.95]

Federal Register notice: FDA publishes a list of information collections that have been approved by OMB under the Paperwork Reduct...

Polyethylene Glycol 3350 Approval Withdrawals Stayed

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Federal Register notice: FDA extends until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription...

FDA Approves Progenics Azedra for Adrenal Tumors

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FDA approves Progenics Pharmaceuticals Azedra for treating some rare adrenal tumors that require systemic anticancer therapy.

Sekisui Diagnostics Sekure HbA1c Assay Cleared

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FDA clears a Sekisui Diagnostics 510(k) for the Sekure HbA1c assay and its use as an aid in diagnosing diabetes mellitus.

Draft Babesiosis Risk Reduction Guidance

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FDA issues a draft guidance with recommendations to reduce the risk of transfusion-transmitted babesiosis.

31 ANDA Approvals Being Withdrawn

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Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants.

CDRH 2019 Experiential Learning Program

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Federal Register notice: CDRH announces its 2019 Experiential Learning Program.

Schakowsky Introduces Drug Pricing Bills

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Rep. Jan Schakowsky (D-IL) introduces four bills intended to lower drug prices.

Nektar NDA for Pain Drug Accepted for Review

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FDA accepts for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid t...

Guide on Peripheral Vascular Atherectomy Devices

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Federal Register notice: FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [5...