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Federal Register Notice: FDA opens a public docket on its proposed criteria for first generic ANDA submissions.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on consumer studies on perceptions of modified risk tobacco products.[ Price : $8.95]
Federal Register Notice: CDER is making available: Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.[ Price : $8.95]
Federal Register Notice: FDA is releasing a guidance: Vaginal Microbicides: Development for the Prevention of HIV Infection.[ Price : $8.95]
Attorney Kurt Karst says Ranbaxy has told a DC federal court that FDA does not have the right to strip the company of two tentativ...[ Price : $8.95]
FDA commissioner Margaret Hamburg meets with Chinese officials this week in China to discuss additional ways in which the two nati...[ Price : $8.95]
FDA releases a draft guidance on Rare Pediatric Disease Priority Review Vouchers that provides information on implementing Section...[ Price : $8.95]
A Tufts Center for the Study of Drug Development analyses says the cost of developing an approved new drug has increased to $2.6 b...