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Albany Molecular Research Resolves 2010 Warning Letter

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FDA issues Albany Molecular Research an inspection close-out letter lifting a 2010 Warning Letter related to its Burlington, MA as...

Pazdur Sees Trial Designs Changing

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CDER Office of Hematology and Oncology Products director Richard Pazdur says clinical trial designs are changing to keep up with m...

High Court May Decide if Truthful Speech Can be Prosecuted

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A Forbes article expresses hope that the Supreme Court will hear former InterMune CEO Scott Harkonens appeal and clarify whether i...

Guidance on Screening HCT/P Donors for Syphilis

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Federal Register Notice: FDA releases a draft guidance: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and C...

Attorney Looks at State Efforts Seeking Drug Company Restitution

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Attorney Anthony Vale reviews the legal principles involved when states bring actions against drug companies alleging false or mis...

FDA Animal Regs Reflect September Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect September approval actions and to reflect a sponsor...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aptalis Pharma US and Globus Medical.

How FDA Dropped Patient Warning Rule from LASIK Approvals

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FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement t...

Hamburg Calls Compounding Bill Just a Step

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FDA commissioner Margaret Hamburg calls a drug compounding bill moving through Congress a step and not as comprehensive as the age...

Merck Filing BLA for HPV Vaccine by Year-end

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Merck says it will file a BLA by the end of the year for its investigational 9-valent human papillomavirus vaccine (V503) followin...