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ICH Meetings to Update on Good Clinical Practice

[ Price : $8.95]

An International Council for Harmonization expert working group announces two meetings (5/18-19) to provide an update on the progr...

Molli Breast Cancer Lesion Marker Cleared

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FDA clears a Molli Surgical 510(k) for Molli, a wire-free localization technology for marking lesions to be removed during breast ...

Acella Pharma Recalls Subpotent Thyroid Drug

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Acella Pharmaceuticals recalls certain lots of its NP Thyroid (levothyroxine and liothyronine) 15-mg, 30-mg, 60-mg, 90-mg and 120-...

Drug Product Communications Info Collection

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Federal Register notice: FDA announces that an information collection entitled Data to Support Drug Product Communications has bee...

Info Collection on Rx Drug Advertising

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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Advertising 21 CFR ...

Updated List of Device Consensus Standards

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Federal Register notice: FDA announces a publication containing modifications to its list of standards FDA recognizes for use in p...

FDA/HHS Withdraw Trump Policy on Drug Stats

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FDA and HHS withdraw a policy statement on drug review transparency that was issued in the final days of the previous administrati...

2 Bills Introduced to Speed Generic Drugs

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U.S. senators Bill Cassidy (R-LA) and Tina Smith (D-MN) introduce two bills with the stated purpose of speeding the development of...

Pacific Medical Recalls Alaris Pump Front Bezel

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Pacific Medical Group recalls the Alaris Infusion Pump Module Model 8100 Front Bezel because components may crack or separate.

Leo Dermatitis Drug Gets Complete Response

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FDA issues Leo Pharma a complete response letter for tralokinumab and its use in adults with moderate-to-severe atopic dermatitis....