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Aeterna Zentaris Prostate Drug Trial Misses Mark

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Aeterna Zentaris says that its benign prostatic hyperplasia drug filed to meet its endpoint in a 39-site European Phase 3 trial.

Guidance on Therapeutic Protein Assays

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Federal Register Notice: FDA releases a draft guidance on assay development for immunogenicity testing of therapeutic proteins.

CDER Making Stealth Comparative Effectiveness Decisions: Pendergast.

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Former FDA deputy commissioner Mary Pendergast warns that CDER is making stealth comparative effectiveness decisions on standard N...

Advisors to Look at Pediatric Safety Reviews

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FDA says its Pediatric Advisory Committee will review safety profiles for 13 drugs at its 12/8 meeting.

Panel Gives Good Grades on FDAs New Leadership

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A panel of FDA Watchers at an industry conference gives the agency new leadership high passing marks on its attempts to improve FD...

Guidance on Liquid Dietary Supplements

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Federal Register Notice: FDA releases a draft guidance on factors that distinguish liquid dietary supplements from beverages from ...

CGMP Violations Found in Providence Inspection

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FDAs Denver District Office warns Provident Pharmaceuticals about CGMP violations and manufacture of unapproved drugs.

FDA Says Modified Steris System 1 Processor Unapproved

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FDA says Steris has failed to transition customers to approved substitutes for its modified and unapproved SS1 Processor used to s...

FDA Approves New Seroquel Indication

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FDA approves AstraZenecas Seroquel XR as adjunctive treatment to antidepressants for adults with major depressive disorder.

FDA Plans Spring 2010 Advisory Meeting on Opioid REMS

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FDA says it will consider information presented by an industry working group on opioid REMS and take its recommendations to an adv...