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Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Nontuberculous Mycobacterial Pulmon...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Su...[ Price : $8.95]
Pfizer and BioNTech say they will seek in the coming weeks an emergency use authorization from FDA for their Covid-19 vaccine in c...[ Price : $8.95]
FDA issues a draft guidance on the use of two sources of real-world data to support regulatory decision-making.[ Price : $8.95]
FDA and the United Kingdom expand their ongoing mutual recognition agreement to include animal drug inspections.[ Price : $8.95]
FDA alerts health care providers on recent information about the potential for differences in procedural outcomes between women an...[ Price : $8.95]
CDER director Patrizia Cavazzoni tells an industry conference that agency inspectors are emphasizing the importance of having in p...[ Price : $8.95]
FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device...