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FDA sends a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische af...[ Price : $8.95]
Federal Register proposed rules: FDA issues two proposed rules that modify certain research requirements regarding approval/oversi...[ Price : $8.95]
Biogen pays $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to...[ Price : $8.95]
Stakeholders make recommendations they say would improve an FDA draft guidance on remote regulatory assessments.[ Price : $8.95]
The Association of Health Care Journalists urges its journalist members to look deeper into FDAs use of advisory committees in its...[ Price : $8.95]
Federal Register final rule: FDA amends the color additive regulations to allow calcium carbonates use in dietary supplement table...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Product...[ Price : $8.95]
FDA concludes after ending a recent pilot program on software as a medical device that a new regulatory paradigm is needed to regu...