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Dr. Reddys Gets FDA-483 After Pre-Approval Inspection

[ Price : $8.95]

FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspec...

FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology

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FDA grants de novo authorization for Caristo Diagnostics CaRi-Heart coronary inflammation technology.

FDA Panel Votes Down Capricor's Duchenne Cell Therapy

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An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, ...

Reviewers Concerned About Data Supporting Replimune Melanoma BLA

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FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of...

Linemaster Switch QS Violations

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FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot ped...

FDA: VasoCorp Selling Unapproved, Misbranded Drugs

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FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.

PhRMA Urges FDA to Clarify Drug Dose Modeling Guidance

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The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative ...

Alkem Labs Plant in India Cited Over OOS Investigations, Quality Systems

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FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing ...

17 Revised Draft Guidances for Certain Generic Peptide Products

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FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the age...

FDA Accepts for Review Saol Therapeutics SL1009 NDA Resubmission

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FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatm...