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Bar Code Label Guidance Out

[ Price : $8.95]

CDER and CBER issue a guidance with answers to 24 typical questions on implementing bar codes on drug and biologics labels.

FDA OKs Axcans H. Pylori Eradicator

[ Price : $8.95]

FDA approves Axcan Pharmas NDA for Pylera, indicated for eradicating ulcer-causing Helicobacter pylori.

FDA Regains Lead on Personal Reimportation Enforcement

[ Price : $8.95]

FDA resumes its lead enforcement role on personal drug reimportation involving mailed prescription drugs coming from Canadian phar...

Medtronic Plans for Drug Stent Approval in 2007

[ Price : $8.95]

Medtronic says it expects to gain FDA approval for its Endeavor drug-eluting coronary stent in 2007.

UK Drug Industry Group Suspends Merck Unit

[ Price : $8.95]

The Association of the British Pharmaceutical Industry suspends Mercks UK business unit for violating its drug promotion code of p...

Cell and Tissue Violations at IVF

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FDAs Detroit District says IVF Michigan had significant deviations from regulations for human cells, tissues, and cellular and tis...

Growth in Rx Drug Use Easing

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A news study says Rx drug expenditure by privately insured people, which has been dropping since 1999, has started to increase aga...

Slowdown in Approvals Not Safety Related: Jenkins

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CDER Office of New Drugs director John Jenkins tells a financial conference that a recent drop in some first cycle approvals is no...

Physicians Say Samples Influence Prescribing

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Some obstetricians and gynecologists surveyed say they believe free drug samples from company representatives influence their pres...

Histatrol Promotional Fax Misleading

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CBER warns Alk-Abello over a Histatrol promotional fax that omitted risk information and use directions.