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FDA issues a draft guidance on CDER critical path innovation meetings with stakeholders on a new drug development methodology or t...[ Price : $8.95]
FDA considers overhauling the way it records inspectional observations on Form 483s.[ Price : $8.95]
Bristol-Myers Squibb withdraws its NDA for a dual regimen of daclatasvir and asunaprevir for treating hepatitis C genotype 1b pati...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Ambco Electronics, ANDAPharm, Hospira Australia, Infopia, Multimmunity, and Nova...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on orphan drugs a...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on user fee waivers, reduct...[ Price : $8.95]
FDA posts a guidance on Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an ...[ Price : $8.95]
Alcobra says a Phase 3 study of its Attention Deficit Hyperactivity Disorder drug metadoxine extended release showed statistically...