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Federal Register Notice: FDA is making available a draft guidance for industry entitled ANDA Submissions Refuse to Receive for La...[ Price : $8.95]
Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 10/30 to discuss a Daiichi Sankyo NDA fo...[ Price : $8.95]
Federal Register Notice: FDAs Center for Tobacco Products will hold a public workshop 12/10-11 to discuss electronic cigarettes.[ Price : $8.95]
Soligenix reaches an agreement with FDA on the design of a Phase 3 clinical trial of its synthetic hypericin product for treating ...[ Price : $8.95]
FDA extends by three months its review of an Impax Pharmaceuticals NDA resubmission for Rytary (carbidopa and levodopa), an invest...[ Price : $8.95]
The Drug and Device Law Blog praises a recent federal court decision protecting some company corporate integrity agreement documen...[ Price : $8.95]
FDA issues a special controls guideline to support classification of a tryptase test system into Class 2 (special controls).[ Price : $8.95]
Attorneys John Lavelle and Jacqueline Gorbey say medical device companies should ensure that they provide technical support reques...