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Astellas Pharma files a supplemental NDA for Tarceva tablets for first-line treatment in patients with locally advanced or metasta...[ Price : $8.95]
FDA publishes a guidance on electronic source data in clinical investigations.[ Price : $8.95]
Momenta says it will ask the Supreme Court to hear its case against Amphastar for using a Momenta patented method in producing a g...[ Price : $8.95]
FDA approves the first seasonal flu vaccine using cultured animal cells rather than fertilized chicken eggs.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, Electronic Source Data in Clinical Investigations.[ Price : $8.95]
Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 1/29-30/13 to discuss a Boehringer Ingelheims S...[ Price : $8.95]
A Partnership for Public Service report says FDA continues to experience workforce and management challenges in keeping up with me...[ Price : $8.95]
FDA issues a draft guidance to remind IRBs about their responsibilities in clinical investigator qualifications, research site ade...