[ Price : $8.95]
Two stakeholders suggest ways to improve an FDA draft guidance on using real-world evidence in medical device regulatory decision-...[ Price : $8.95]
FDA places a partial clinical hold on AstraZenecas enrollment of new patients with head and neck squamous cell carcinoma in clinic...[ Price : $8.95]
Five organizations call on President Obama to reduce the 12-year market exclusivity period to seven years for biologic drugs in an...[ Price : $8.95]
FDA says that new data indicate continuing increased mortality and neurological risks with use of SynCardias Temporary Total Artif...[ Price : $8.95]
The CDER Office of Generic Drugs issues a MAPP with policies and procedures for review of Bio-INDs.[ Price : $8.95]
Two stakeholders suggest improvements to an FDA/HHS guidance on written procedures for institutional review boards.[ Price : $8.95]
Four stakeholders raise concerns about and recommend changes to two draft guidances on drug compounding.[ Price : $8.95]
The International Society for Pharmaceutical Engineering asks FDA for additional clarifications to a draft guidance on data integr...