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Pediatric Panel to Hear Adverse Event Reports

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Advisory Committee will meet 11/16 to hear reports and updates on adverse event reports fo...

No Risk Info on Maxair Flash Card

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DDMAC says a 3M Maxair flash card omits important information and makes unsubstantiated superiority claims.

Court Downplays FDAs Preemption Stance

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Ruling in a Michigan class action product liability suit, the Second U.S. Circuit Court of Appeals minimizes FDAs preemption argum...

Guidance on PMA Annual Reports

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Federal Register Notice: FDA releases a draft guidance on annual reports for approved premarket approval applications.

OMB Extends Expiry Date for Old MedWatch Form

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Federal Register Notice: OMB extends the expiration date for companies who are using the prior version of Form FDA 3500A for the M...

Dental Panel to Vote on PMA

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Federal Register Notice: FDAs Dental Products Panel will meet 11/9 to vote on a PMA for a collagen material for oral maxillofacial...

FDA Orphan Drug Status for Brain Cancer Drug

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FDA grants an orphan drug designation to Reata Pharmaceuticals for its experimental brain tumor drug RTA 744.

FDA Priority Review for New Humira Indication

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FDA grants Abbott a priority review for a supplemental BLA on Humira as a treatment for moderately to severely active Crohn's dise...

FDA Mulls New Court Bid on Rx Compounding

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Contrary to expectations, FDA seems ready to accept a Texas court defeat on drug compounding and to instead mount a new prosecutio...

Haffner Leaving FDA for Amgen

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FDA orphan products director Marlene Haffner announces her retirement to join Amgens Washington office.