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Federal Register Final Rule. FDA amends certain regulations relating to citizen petitions to discourage their use to improperly de...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance on Non- Inferiority Clinical Trials to Establish Effectiveness.[ Price : $8.95]
FDA denies a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the D...[ Price : $8.95]
FDA posts a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling r...[ Price : $8.95]
CDER researchers say that links to disease awareness Web sites from branded prescription drug sites may lead to confusion and misp...[ Price : $8.95]
Mylan files a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentechs Herceptin), indicated to treat certain HER2...[ Price : $8.95]
FDA accepts an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell dis...[ Price : $8.95]
Two professors say FDA should use a partial-approval system for drugs rather than the currently all-or-nothing approach.