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Dental Panel to Vote on PMA

[ Price : $8.95]

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

[ Price : $8.95]

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

Court Approves Generic Ovcon Settlement

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A federal judge approves an FTC settlement with Warner Chilcott over the compays efforts to delay entry of Barr Laboratories gener...

AbTox Case Judge Gives Reasons for Jail Terms

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Consulting editor John Scharmann reviews a new order by the judge in the AbTox case in which he gives the reasons for his prison s...

FDA OKs Novartis Hepatitis B Drug

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FDA approves a Novartis NDA for Tyzeka, indicated for treating adults with chronic hepatitis B.

Nearly 50% Want More Regulation of Drug Companies

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Some 48% of adults polled say there should be stronger regulation of drug companies.

KV Asks Re-listing of Toprol-XL Patent

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KV files a citizen petition asking FDA to relist a delisted Toprol XL patent.