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Info Collection Extension for Patent Submissions

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for NDA patent submission and listing requirements...

Proposal to Add 5 Bulk Drugs for Compounding

[ Price : $8.95]

Federal Register proposed rule: FDA proposes to add five additional bulk drug substances to its drug compounding list.

FDA Funding Functional Capacity Assessment Tool

[ Price : $8.95]

FDA funds VeraSci research into a virtual reality functional capacity assessment tool.

Mallinckrodt Paying $15 Million in False Claims Act Case

[ Price : $8.95]

The Justice Department says Mallinckrodt is paying $15.4 million to resolve allegations that it paid illegal kickbacks to doctors ...

Commissioner Search Down to 3: BioCentury

[ Price : $8.95]

BioCentury identifies the names of three potential FDA commissioner candidates sent to the White House.

Former Officials Find New Roles After FDA

[ Price : $8.95]

Former CDER associate director for genomics Felix Frueh joins NDA Partners as an expert consultant, and former FDA chief of staff ...

medPhoton ImagingRing CT Scan Cleared

[ Price : $8.95]

FDA clears a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system.

Arthrosurface Toe Fixation Cleared by FDA

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FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a dist...

Combination Product Labeling Contents

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Three stakeholders suggest changes to an FDA draft guidance on instructions for use in combination product labeling.

Too Few Antibiotics in Development: Pew Report

[ Price : $8.95]

A Pew Charitable Trusts issue brief says there are not enough new antibiotics in the development pipeline to meet the need.