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FDA Issues Least Burdensome Guidance

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FDA publishes a draft guidance explaining its view of Congress requirement that it apply least burdensome principles to medical de...

High Throughput Sequencing Can be Standardized: FDA Research

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FDA scientists say it is possible to standardize high throughput sequencing to screen biologics for contamination.

Comments on PDMA Information Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension for Prescription Drug Marketing Act of 1987 Ad...

Comments Sought on GMP Info Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension for Current Good Manufacturing Practice Regulat...

Workshop on Patient-focused Drug Development

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Federal Register notice: FDA announces a 3/19/18 public workshop entitled Patient-Focused Drug Development: Developing and Submitt...

Appeals Court Rules Against Amgen in Neupogen Biosimilar Case

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The Federal Circuit Court of Appeals rules against Amgen in the continuing dispute between it and Sandoz over application of provi...

FDA Still Against Using Morcellators for Most Fibroids

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An updated FDA assessment says the agency continues to caution against using laparoscopic power morcellators to treat presumed ute...

2014 Baxter FDA-483 Released

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FDA releases the FDA-483 issued after a 2014 inspection at Baxter Healthcare.

Chemence Medicals Exofin Fusion Skin Closure Device Cleared

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FDA clears a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds.

FDA Wants More Consumer Information Available

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HHS lists drug and medical device regulatory priorities for FDA.