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FDA releases a guidance entitled: Medical Device User Fee Small Business Qualification and Certification.[ Price : $8.95]
An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain in...[ Price : $8.95]
FDA grants PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replac...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for Medical Device Recall Authority (OMB Control N...[ Price : $8.95]
Federal Register notice: FDA announces a 9/14 public workshop entitled Advancing the Development of Pediatric Therapeutics: Advanc...[ Price : $8.95]
The Senate passes a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacte...[ Price : $8.95]
Federal Register notice: FDA announces that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Ant...