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FDA OKs Boston Scientific Ablation Catheter, Steerable Sheath

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FDA approves Boston Scientifics IntellaTip MiFi XP catheter for ablation of atrial flutter and grants 510(k) clearance for its Zur...

Parallel QbD Assessment Worked Well: FDA

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FDA says a parallel assessment with European regulators of quality-by-design elements in a marketing application was useful.

FDA Expresses Aseptic Practice Concerns at Promed Plant

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FDA warns Sentiss Pharma about CGMP violations at its Promed Exports drug manufacturing facility on Himchal Pradesh, India.

FDA Grants Breakthrough Designation for Novartis Drug

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FDA grants Novartis a breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis.

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Conair Corp. Hair Labs International, Healing Dives, Hyperbaric Options, LifeServ...

FDA Begins Secure Supply Chain Pilot Program

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Federal Register Notice: FDA starts the Secure Supply Chain Pilot Program to assist in preventing adulterated drugs from entering ...

More Calls for Trusted Importer Program

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A drug manufacturer and importer adds its support to recent calls for FDA to create a trusted importer program to ease its resourc...

QS Problems Found at Soleetech

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FDA warns Soleetech Corp. about Quality System and Medical Device Reporting regulation violations at its Taipei, Taiwan, medical d...

FDA Wants Comments on Demographic Subgroups in Trials

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FDA opens a docket for comments on its report on clinical trial participation by demographic subgroups.

CHPA Surprised at Contract Manufacturing Guidance Detail

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The Consumer Healthcare Products Association says it is surprised at the amount of detail FDA included in a draft guidance on qual...