FDA Clarifies Requirements Regarding Submission of Manufacturing Establishment Information
A Renewed Focus on Quality: FDA Issues Proposed Rule Amending GLP Regulations
“Institutional Review Board (IRB) Written Procedures” Draft Guidance and NIH’s “Single IRB Policy” Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research
FDA Publishes Final Guidance on Physical Attributes of Generics
CEO Media Statements Draw Additional Scrutiny
Recent FDA Metrics Show Increase in Reported Violations from BIMO Inspections
Who’s Who Legal Names Hogan Lovells as Top Global Life Sciences Practice
FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging
Less is More in FDA’s Eyes: FDA’s Revised Draft Guidance on Disclosing Risk Information
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