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The 510(k) Coalition says FDA should ensure that the risk profile of Class 2 and Class 1 reserved medical devices justifies a prem...[ Price : $8.95]
Allergan says it has filed an ANDA seeking approval to market posaconazole delayed-release tablets (100mg), a generic version of M...[ Price : $8.95]
CDRH chief scientist William Maisel pens an opinion piece in USA Today, defending the agencys actions to prevent patient infection...[ Price : $8.95]
Stakeholder groups praise FDA for its collaborative processing in developing a draft guidance on treatments for Duchenne muscular ...[ Price : $8.95]
FDA posts a draft guidance on Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Det...[ Price : $8.95]
FDA approves an expanded indication for Octapharmas Wilate [von Willebrand factor/coagulation factor VIII complex (human)] to incl...[ Price : $8.95]
FDA extends by three months its target review action date on a Bristol-Myers Squibb supplemental BLA for Opdivo.[ Price : $8.95]
FDA approves Purdue Pharmas Oxycontin (oxycodone hydrochloride) extended-release tablets for use in pediatric patients aged 11 to ...