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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.

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.

Next Presidents Impact on Drug Ads Discussed

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Former FDA chief counsel Richard Cooper gives FDLI a preview of likely effects of the presidential election on drug advertising.

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Panelists at FDLIs Advertising & Promotion Conference express widely disparate views concerning DDMACs draft guidance on use of re...

DDMAC Cites Forest for Bystolic Journal Launch Ad

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DDMAC says a Forest Laboratories journal ad for Bystolic contained unsubstantiated superiority and efficacy claims and omitted imp...

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...

FDA Finalizes Minor GMP Revisions

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FDA finalizes minor GMP revisions that were proposed late last year in an attempt to modernize its requirements for drug and biolo...