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Biovail Paying $24 Million for Marketing Violations

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Biovail is sentenced to pay $24 million in criminal and civil penalties after pleading guilty to conspiracy and kickback charges i...

FDA Corrects Date on Tobacco Info

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Federal Register Notice: FDA corrects the comment submission date for a Federal Register notice on submitting tobacco product esta...

FDA Approves 4 H1N1 Flu Vaccines

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FDA approves four companies H1N1 flu virus vaccines for 2009.

FDA Lasik Response to FDA Webview Challenged

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LASIK Surgery Watch challenges FDA assertions in its response to FDA Webviews interview with former FDAer Morris Waxler who said t...

FDA Asks Pancrecarb Questions

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An FDA complete response letter asks Digestive Care for more information on its Pancrecarb but does not call for additional trials...

FDA Explains Generic Starlix Decision

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FDA tells applicants for generic Starlix how it reached its decision on forfeiture of 180-day exclusivity.

How CDRH Science Could Help Boost Industry Innovation

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CDRH associate director for postmarket operations Jonathan Sackner-Bernstein enthuses an industry audience with visions of how Cen...

CDER Implementing New 21st Century Review Process

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After two years of planning, training and two pilot programs, CDER begins implementing its new 21st Century Review process on a wi...

FDA/EMEA Orphan Status for Pancreatic Cancer Drug

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FDA and the EMEA grant Antisense Pharma an orphan drug designation for its investigational drug trabedersen and its use in treatin...

Workshop on Pediatric Clinical Trials

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Federal Register notice: FDA holds a public workshop entitled Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and C...