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FDA OKs Genentechs Avastin for Ovarian/Fallopian Tube Cancers

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FDA approves Genentechs Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carbop...

Comments Extended on Abuse-deterrent Properties for Opioids

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Federal Register Notice: FDA extends the comment period related to its public meeting on Pre-Market Evaluation of Abuse-Deterrent ...

CDER New Drugs Director Jenkins to Retire

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After almost 25 years at FDA, CDER Office on New Drugs director John Jenkins announces his retirement.

Comments Sought on Device Pediatric Use Information

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Federal Register Notice: FDA seeks comments on an information collection extension request related to a guidance on Providing Info...

Guidance on Clin Pharm Labeling for Drugs

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Federal Register Notice: FDA makes available a guidance entitled Clinical Pharmacology Section of Labeling for Human Prescription ...

FDA Clears Kyocera Medical Total Hip System

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Kyocera Medical Corp. receives 510(k) clearance for its Initia Total Hip System which features Bioceram Azul (blue) zirconia-tough...

Kite Pharma Begins BLA for CAR-T Cell Therapy

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Kite Pharma begins a rolling BLA submission for KTE-C19 (axicabtagene ciloleucel) as a treatment for patients with relapsed/refrac...

FDA Posts Transcript of Device User Fee Program Meeting

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FDA posts a transcript of its 11/2 public meeting on Medical Device User Fee Amendments that discussed proposed recommendations fo...

Guidance on Clin Pharm Labeling for Drugs

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Federal Register Notice: FDA makes available a guidance entitled Clinical Pharmacology Section of Labeling for Human Prescription ...

Comments on Device GMPs and Quality System Regulations

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Federal Register Notice: FDA seeks comments on an information collection extension request related to Medical Device: Current Good...