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Petition Seeks Doryx Equivalence Assurances

[ Price : $8.95]

Warner Chilcot and Mayne Pharma ask FDA to rule that enteric-coated doxycycline hyclate tablets are not equivalent to their Doryx.

Baucus Calls for 2009 Healthcare System Reform

[ Price : $8.95]

Sen. Max Baucus calls for healthcare reform that includes more restrictions on industry-physician relationships and greater enforc...

FDA Cites Indian Generic Maker After GMP Inspection

[ Price : $8.95]

Another Indian generic drug maker, Lupin, finds itself in FDA hot water after a recent inspection cited 15 manufacturing deficienc...

Panel Backs Remoxy Approval

[ Price : $8.95]

FDA advisors recommend approval of Pain Therapeutics Remoxy with labeling that describes it as tamper-resistant rather than abuse-...

Advisor Input Sought on Dermal Fillers

[ Price : $8.95]

FDA asks an advisory panel to consider the safety and evaluation of potential new indications for dermal filler devices.

Pediatric Advisory Panel to Meet

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 12/9 to discuss an IRB referral of a clinical investigation o...

Ethics Panel to Discuss Child Stem Cell Transplants

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Ethics Subcommittee will discuss a clinical investigation of granulocyte colony stimulatin...

FDA Seeks Injunction Against Generic Maker Actavis

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FDA seeks a permanent injunction against Actavis Totowa over continuing compliance issues involving drug products made at its faci...

Ferumoxytol Resubmission Response Complete

[ Price : $8.95]

FDA says Amag Pharmaceuticals resubmission of its ferumoxytol NDA is a complete response.

Further CorCap Study Questioned

[ Price : $8.95]

Public Citizen says FDA approval of Acorn Cardiovasculars CorCap without further advisory committee review would abdicate its resp...