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Draft Inspection Refusal Guidance

[ Price : $8.95]

FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...

FDA Stem Cell Therapy Regulation at Risk: Attorneys

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Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...

Endocrinologic/Metabolic Drugs Panel Renewed

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Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.

United Therapeutics Used Priority Voucher on Tyvaso

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Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics sup...

States Pushing for Canadian Drug Imports: Report

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A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signali...

Drug Promotion Research on Mechanism of Action OKd

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Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Pr...

FDA Debars Kempema for 5 Years

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Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any d...

Harmonize Innovative Manufacturing Regulation: PhRMA

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Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufac...

AdvaMed Supports Breakthrough Device Guidance Updates

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AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.

VALID Could Hurt Home Sample Testing: Attorneys

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Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect te...