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FDA Adds New Information Chief from J&J

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Former Johnson & Johnson Pharmaceutical R&D chief information officer (CIO) Eric Perakslis joins FDA as its new CIO.

Dont Approve Ferriprox: Public Citizen

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Public Citizen calls on FDA not to approve ApoPharmas Ferriprox because the company has failed to demonstrate the drugs safety and...

Guidance on Box Warning Sections of Drug, Biologic Labeling

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Federal Register Notice: FDA releases a guidance on drafting warnings and precautions, contraindications, and box warning sections...

Workshop on Infectious Diseases Relevant to Blood/Blood Products

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Federal Register Notice: FDA schedules a public workshop 11/29 on data and data needs to advance risk assessment for emerging infe...

CBER Revises Biological Product Deviation Codes

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CBER revises its listing of Biological Product Deviation Codes for manufacturers filing a reportable event to FDA.

PDA Praises Flexibility in ICH Q11

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The Parenteral Drug Association praises manufacturer flexibility built into International Conference on Harmonization Q11 guidance...

Reps Want to Look at Medical Device Regs

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Democratic leaders of the House Energy and Commerce Committee target CDRH medical device review and postmarket surveillance perfor...

Coopers Says it is Completing Recall

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CooperVision says it is cooperating with FDA to complete an August recall of certain Avaira Toric contact lenses.

Guidance on Incorporating Identifiers into Drugs for Anti-counterfeiting

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Federal Register Notice: FDA releases a guidance on incorporating physical-chemical identifiers into solid oral dosage form drug p...

FDA Clears CorMatrix Carotid Repair Device

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FDA clears a CorMatrix Cardiovascular 510(k) for the CorMatrix Extracellular Matrix (ECM) for Carotid Repair.