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King Introduces New Bicillin L-A

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FDA says King has launched a revised Bicillin L-A, which had been in short supply and for emergency use only.

Gottlieb Says He Wasnt Criticizing FDA on RiskMAPs

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FDA deputy commissioner for medical and scientific affairs Scott Gottlieb says his concerns about expanding RiskMAPs, reported yes...

Latest EIRs, FDA-483s Received from FDA

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FDA Webview posts to its site the latest FDA-483s, EIRs and related correspondence received from FDA for Cardinal Health, Hitachi ...

Von Es Nomination Gains Steam with Frist Cloture Petition

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Senate leader Bill Frist (R-TN) files a cloture petition seeking to remove the holds on acting commissioner Andrew von Eschenbachs...

GSK Opens RAISE Eltrombopag Trial

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GSK opens a long-term trial of its investigational eltrombopag for previously-treated patients with chronic idiopathic thrombocyto...

Companies Want ICH Pharmacopeia Agreement

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Comments on a draft harmonization guidance say any of the three signatory pharmacopeias should not be able to say they have harmon...

FDA OKs Alimeras OTC Eye Itch Drops

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FDA approves an Alimera Sciences Inc. NDA for Alaway, an OTC eye allergy treatment for itch eyes.

Ethical Issues Have FDA in a Dilemma

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Consulting editor John Scharmann reviews ethical issues surrounding FDA advisory advisory committees and concludes its time to bit...

Steeves Loses Suit Against FDA, Crawford, et al

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A Virginia federal judge rules against former FDA whistleblower Robert F. Steeves in his lawsuit charging former commissioner Lest...

Ad Spending Projected to Grow

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Merrill Lynch analysts see increased drug ad spending for 2007 despite congressional interest in regulating DTC.