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FDA Clears Siemens NAEOTOM Alpha CT Device

[ Price : $8.95]

FDA clears the Siemens Medical Solutions NAEOTOM Alpha improved CT imaging device, described by the agency as the first major CT t...

CDER Drug Safety Staff Changes

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CDER drug safety operations (DSO) associate director Terry Toigo retires and, in the interim, DSO senior staff member Amy Ramanadh...

Appeals Court Reverses Catalyst Firdapse Loss to FDA

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The 11th Circuit Court of Appeals tells a Florida federal court it erred in granting summary judgment to FDA and Jacobus over orph...

Bipartisan Drug Supply Chain Bill Introduced

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Bills in the House and Senate would create an emergency supply of active pharmaceutical ingredients needed to make essential gener...

Apellis Plans NDA for Blindness Drug

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Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic at...

Ex-CDER Official Laughren Retained by PharmaTher

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PharmaTher Holdings retains former CDER antipsychotic guru Thomas Laughren as a regulatory affairs advisor to help a depression th...

FDA Approves AbbVies Qulipta for Migraine Prevention

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FDA approves AbbVies novel migraine prevention drug Qulipta.

FDA Outmatched, Overwhelmed by Stem Cell Industry: Professor

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The Associated Press reports that FDA has been unsuccessful in asserting regulatory control over rapidly proliferating private ste...

New Drug Product Impurities ICH Guidance

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FDA publishes a revised International Conference on Harmonization guidance on impurities in new drug products.

Safety Reporting Investigator Responsibility Guidance

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FDA publishes a draft guidance on investigator responsibilities for safety reporting for INDs and IDEs.