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CDER Increases Remote Regulatory Assessments

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CDER Office of Compliance director Donald Ashley tells a Food and Drug Law Institute conference that FDA is continuing to explore ...

Biogen Pays $22 Million on Anti-Kickback Charges

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Biogen agrees to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations a...

FDA Updates Off-Patent, Off-Exclusivity List

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FDA posts the latest six-month update of its list of off-patent, off-exclusivity drugs without approved generics.

Phoenix Biotechnology Marketing Unapproved Covid Drug: FDA

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FDA warns Phoenix Biotechnology and Avila Herbals the Oleander 4X homeopathic drug they are marketing to address serious condition...

FDA 2020 Device Law and Policy Activities Analyzed

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Two Mintz attorneys review FDA medical device regulation and policy in 2020.

Change OTC Acetaminophen Childrens Dosage Schedule: Petition

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Parenteral Technologies asks FDA to amend the dosing schedule for single-ingredient acetaminophen for use in children ages 2-4.

Penumbra Recalls JET 7 Reperfusion Catheter

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Penumbra recalls all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology due to a risk of unexpect...

FDA Warns Against Some Online Male Products

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FDA cautions consumers not to use some male enhancement and weight loss products sold through Amazon and eBay.

Guidance on Drug Complex Innovative Trial Designs

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Federal Register notice: FDA posts a final guidance on interacting with the agency about drug complex innovative trial designs.

FDA Approves MacroGenics Margenza

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FDA approves MicroGenics Margenza for some HER2-positive metastatic breast cancers.