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Hospital Efforts Against Superbugs May Be Thwarted at CVM

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Consulting editor John Scharmann says new cooperative efforts by hospitals against the development of antibiotic superbugs may be ...

DDMAC Guide on Reprints Provokes Controversy

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Panelists at FDLIs Advertising & Promotion Conference express widely disparate views concerning DDMACs draft guidance on use of re...

Public Meeting on Clinical Research

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Federal Register Notice: FDA Dallas District and the Society of Clinical Research Associates will hold a workshop 11/19-20 on FDA ...

Vaccine Development Guidance Out

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FDA issues a guidance to help sponsors develop vaccines to protect against global infectious diseases.

Ortho Biotech Submits Doxil sNDA

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Ortho Biotech submits an sNDA to FDA for a new indication for Doxil in combination with Taxotere.

Regs to Prevent Monkeypox Removed

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Federal Register Final rule: FDA removes regulations restricting capture, transport and release of African rodents, prairie dogs t...

CGMP Revision on Aseptic Processing

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Federal Register Final rule: FDA revises CGMP regulations for finished pharmaceuticals on aseptic processing, use of asbestos filt...

Woodcock Pushes for Regulatory Harmonization

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CDER director Janet Woodcock calls for global regulatory harmonization effort to standardize product reviews and inspections.

FDA Considers INDs Applications for Trial Certification

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FDA says IND submissions are included in the FDAAA requirement for certification that clinical trial information has been posted o...

Quarterback Romo in Abbott Prostate Cancer Program

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Quarterback Tony Romo and his father are appearing in an Abbott-funded TV spot to encourage men to be tested for prostate cancer.