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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...[ Price : $8.95]
CDER Office of Hematology and Oncology Products director Richard Pazdur says clinical trial designs are changing to keep up with m...[ Price : $8.95]
A Forbes article expresses hope that the Supreme Court will hear former InterMune CEO Scott Harkonens appeal and clarify whether i...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and C...[ Price : $8.95]
Attorney Anthony Vale reviews the legal principles involved when states bring actions against drug companies alleging false or mis...[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect September approval actions and to reflect a sponsor...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Aptalis Pharma US and Globus Medical.[ Price : $8.95]
FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement t...