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WLF Says DTC Tax Bill Unconstitutional

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Attorneys Arnold Friede and John Kamp say Rep. Pete Starks bill to ban tax deductions for some DTC advertising is unconstitutional...

King Reports Avinza Patent Challenge

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King Pharmaceuticals says Iceland-based Actavis has filed an ANDA with a Paragraph 4 certification challenging a utility patent on...

More FDA Resources Needed for Foreign Inspections

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Consulting editor John Scharmann reviews the burgeoning use of foreign facilities to make drugs for the U.S. market in the light o...

Medimmune says FluMist Issues Resolved

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Medimmune says it has resolved issues cited by FDA in a Warning Letter following an inspection of its Speke, UK, FluMist bulk manu...

Generic Drugs Need User Fees, Bradshaw Says

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Departing FDA chief counsel Sheldon Bradshaw tells the generic drug industry to get its act together in support of user fees as th...

Court Nixes Stay on Generic Protonix

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A federal judge refuses to give Wyeth and Nycomed a preliminary injunction to stop Teva and Sun from marketing generic Protonix be...

FDA Raises 2 Issues as Anemia Drugs Head to Panel

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FDA focuses on two issues as it heads into an advisory committee meeting 9/11 to evaluate updated information on the risks and ben...

Improving Medical Publication Efforts

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Cutting Edge Information identifies five principles drug companies should follow for maximum benefit from medical publications.

Administration Responds to Drug Industry Patent Concerns

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The Bush administration says it opposes a provision in patent reform legislation that drug companies fear would limit their abilit...

Guidance on Spore-forming Biological Intermediates

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Federal Register Notice: FDA releases a guidance on manufacturing biological intermediates and drug substances using spore-forming...