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FDA Guidance on Flow Cytometric Devices

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FDA posts a draft guidance on Flow Cytometric Devices that is intended to address certain issues that arise in premarket submissio...

PhRMA, BIO Attack Exclusivity Guidance for Biological Products

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Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization say an FDA draft guidance on Refe...

Oregon Compounding Recalls Products Due to Sterility

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Oregon Compounding Centers recalls certain unexpired human and veterinary sterile products due to a lack of sterility assurance.

FDA Approves Helsinn NDA for Anti-nausea Drug

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FDA approves a Helsinn Healthcare NDA for Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoin...

Hamburg Announces Key Staff Changes

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FDA commissioner Margaret Hamburg appoints Denise Esposito from the Office of Chief Counsel as her new chief of staff, and acting ...

FDA, SOCRA Workshop on Clinical Trial Requirements

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FDA and the Society of Clinical Research Associates plan a Clinical Trial Requirements, Regulations, Compliance, and Good Clinical...

FDA OKs Lutonix PMA for Transluminal Angioplasty Catheter

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FDA approves a Lutonix PMA for its 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter, the first drug-coated b...

Final Guidance on Exclusivity Decisions for Combo Drugs

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FDA publishes a final guidance on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.

FDA Approves Gileads New Combo Drug for Hepatitis C

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FDA approves a Gilead NDA for Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.

Amgen Success in Humira Biosimilar Phase 3 Study

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Amgen says a Phase 3 study evaluating it biosimilar candidate ABP 501 compared with Abbotts Humira (adalimumab) in patients with m...