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Generic Drug Adverse Event Liability Still Evolving

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Attorney Steven Casey says the law remains unsettled on the question of who is liable for adverse reactions patients experience wh...

Stakeholders May Suggest IMDRF Work Items

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CDRH associate director for international affairs Kimberly Trautman says that medical device stakeholders worldwide have an opport...

Advisors Asked for Anthrax Drug Opinion

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FDA asks its Anti-infective Drugs Advisory Committee to comment on the efficacy and safety of Human Genome Sciences raxibacumab fo...

Changes Made in Cellular, Tissue, and Gene Therapies Meeting

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Federal Register Notice: FDA amends a notice of a 11/29 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to m...

Track and Trace Begins at Lot Level: Law Firm

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A bill being floated on Capitol Hill to establish a nationwide drug tracking system allows tracking at the lot level and not at th...

FDA OKs GI Dynamics EndoBarrier Trial in Diabetics

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FDA grants approval for GI Dynamics to initiate a clinical trial of EndoBarrier for treating patients who have uncontrolled Type 2...

Neuraltus Looking to Phase 3 ALS Drug Trial

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Neuraltus says it is planning a Phase 3 trial of its NP001 in patients with Lou Gehrigs disease.

FDA Approves First PMA Module for Surgical Adhesive

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FDA approves the first of four PMA modules submitted by Cohera Medical for its TissuGlu Surgical Adhesive product.

FDA Accepts Applications for Latuda Expanded Indications

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FDA accepts for review two applications from Sunovion for expanded indications for its schizophrenia drug Latuda.

Ortho Molecular Selling Unapproved New Drugs: Letter

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FDAs Minneapolis District Office warns Ortho Molecular Products that it is selling unapproved new drugs that are mislabeled.