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FDA Issues PET Drug Guidance

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FDA issues a guidance with its thinking on how PET drug manufacturers can comply with cGMP regulations.

More FDA Effort Needed for Safety Responsibilities: GAO

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The Government Accountability Office says that FDA should develop a comprehensive plan and timeline for transferring more responsi...

Generic Biologics Still an Open Issue in Health Reform

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House and Senate health reform bill both support 12 years market exclusivity for branded biologics facing generic competition, but...

FDA Publishes Patient-report Outcomes Guidance

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FDA issues a guidance explaining how it reviews and evaluates patient-reported outcome instruments used to support medical product...

FDA Staff Concerned About Cayston Trials

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FDA tells the Anti-infective Drugs Advisory Committee that there are staff concerns about the clinical trials submitted to support...

Dey Wants FDA Restrictions on Generic EpiPens

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Dey Pharma petitions FDA not to approve generic EpiPen ANDAs unless they have exactly the same design, operation, and function, in...

Drug Ad Spend Down Slightly in 2009

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TNS Media Intelligence says that drug company ad spending has been essentially flat in the first nine months of this year compared...

Administration Increases Open Government Efforts

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The Obama Administration lays out deadlines for agencies to improve their open government activities.

Burzynski IRB Violations Cited

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FDA warns Burzynski Research Institute IRB about multiple violations of laws and regulations intended to protect human subjects.

Grassley Asks 31 Health Organizations for Industry Funding Info

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Sen. Charles Grassley asks 31 health and medical professional organizations for detailed information on their funding from drug an...