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Extend Marketing Exclusivity for Some Drug Combinations?

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Reps. Bilbray, Maloney, and DeLauro introduce legislation to provide additional exclusivity for drugs designated by FDA as signifi...

FDA Withdraws Approval of NADA, 3 ANADAs

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Federal Register Final rule: FDA amends the animal drug regulations to withdraw approval of one NADA and three ANADAs because they...

CDER Plans Clinical Investigator Training Course

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Federal Register Notice: CDER will co-sponsor a training course 11/13-15 for clinical investigators in College Park, MD.

Oncologists Doing Most with Social Media

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A OneKey analysis of healthcare practitioner use of social media finds that oncologists are more active in social media than other...

Celltex to Appeal FDA Product Designation

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Celltex Therapeutics says it will appeal a recent FDA decision that the process it uses to multiply adult stem cells is subject to...

Reckitt Benckiser Pushes Buprenorphine Pediatric Safety

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Reckitt Benckiser petitions FDA to take steps to ensure pediatric safety with drug products containing buprenorphine for treating ...

Research Article Retractions Due to Misconduct: Study

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Retraction Watch says a new study published in the Proceedings of the National Academy of Sciences demonstrates that fraud plays a...

FDA Reminds Generic Drug Facilities to Self-Identify

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Federal Register Notice: FDA notifies generic drug facilities that they must provide identification information to FDA by 12/3 for...

New Degenerative Disease Research Model

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University of California Irvine researchers say a genetically modified mouse they developed may help in finding a cure for several...

Guidance on Generic Drug Completeness Assessments

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Federal Register Notice: FDA releases a draft guidance, Initial Completeness Assessments for Type II API DMFs Under GDUFA.